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Adverse Event Report

B. BRAUN MEDICAL, INC/CARDIOVASCULAR DIV GOODTEC THERMODILUTION BALLOON CATHETER FLOW-DIRECTED BALLOON THERMODILUTION CATHETER   back to search results
Model Number T147
Event Date 04/01/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Return reason: cut distal adhesive band of balloon. Analysis determined: investigation found that the distal adhesive band had lifted away from the catheter tubing due to insufficient adhesive. Unit was used in vivo. This was not determined until analysis was completed. No further info is available on the pt's status. Corrective action taken: the corrective action is that mfg and quality assurance personnel have been notified. Both the frequency and severity of this type of incident will be closely monitored to determine if further remedial action is necessary.

 
Manufacturer Narrative

Disclaimer: b. Braun medical inc. Is submitting this report to the fda in accordance with the federal register, 21 cfr part 803 (medical device reporting) dated december 11,1995/ b. Braun medical inc. Does not intend this report or info submitted under this part as an admission that the device, b. Braun medical, inc. , or any of it's employees caused or contributed to a reportable event. Return reason: cut distal adhesive band of balloon. Analysis: investigation found that the distal adhesive band had lifted away from the catheter tubing due to insufficient adhesive. Corrective action: the corrective action is that mfg and quality assurance personnel have been notified. Both the frequency and severity of this type of incident will be closely monitored to determine if further remedial action is necessary.

 
Search Alerts/Recalls

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Brand NameGOODTEC THERMODILUTION BALLOON CATHETER
Type of DeviceFLOW-DIRECTED BALLOON THERMODILUTION CATHETER
Baseline Brand NameGOODTEC BALLOON THERMODILUTION CATHETER
Baseline Generic NameFLOW-DIRECTED BALLOON THERMODILUTION CATHETER
Baseline Catalogue Number417D1014/I
Baseline Model NumberT147
Other Baseline ID NumberPN604057
Baseline Device FamilyTHERMODILUTION CATHETER (PUR)
Baseline Device 510(K) NumberK841639
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed08/12/1984
Manufacturer (Section F)
B. BRAUN MEDICAL, INC/CARDIOVASCULAR DIV
18 olney ave., bldg. #44
cherry hill NJ 08003 1607
Manufacturer (Section D)
B. BRAUN MEDICAL, INC/CARDIOVASCULAR DIV
18 olney ave., bldg. #44
cherry hill NJ 08003 1607
Manufacturer (Section G)
B. BRAUN MEDICAL, INC.
1940 olney ave, ste 200
cherry hill NJ 08003 1607
Manufacturer Contact
chris watt
18 olney ave., bldg. #44
cherry hill , NJ 08003-1607
(609) 751 -2080 ext 114
Device Event Key167748
MDR Report Key172505
Event Key162115
Report Number2243801-1998-00020
Device Sequence Number1
Product CodeDYG
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device EXPIRATION Date10/31/1999
Device MODEL NumberT147
Device Catalogue Number417D1014/I
Device LOT NumberM476660
OTHER Device ID NumberPN604057
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/14/1998
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/14/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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