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Adverse Event Report

BARD ENDOSCOPIC TECHNOLOGIES, C.R. BARD MARKED SPRINTIP GW GUIDEWIRE   back to search results
Model Number 61 000150
Device Problem Tip breakage
Event Date 09/29/2003
Event Type  Malfunction  
Event Description

Device was opened from its package, was sterilized and was placed in a bag. Contact states device was cleaned manually with soap and water and then autoclaved. When the md opened the bag, it was noted that the flexible metal tip detached. Device had not been used previously.

 
Manufacturer Narrative

A micropscopic review and a comparison with other marked guidewire units determined that the guidewire failed due to a weak solder joint. The solder did not flow properly between the spring tip and the wire. Neither the spring tip component nor the wire were damaged or broken. No lot number was provided; therefore no device history review was possible. Manufacturing has been made aware of this incident and co will continue to monitor.

 
Search Alerts/Recalls

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Brand NameMARKED SPRINTIP GW
Type of DeviceGUIDEWIRE
Baseline Brand NameMARKED SPRINTIP GW
Baseline Generic NameGUIDEWIRE
Baseline Catalogue Number000150
Baseline Model Number000150
Baseline Device FamilyGUIDEWIRE
Baseline Device 510(K) NumberK853274
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/19/1986
Manufacturer (Section F)
BARD ENDOSCOPIC TECHNOLOGIES, C.R. BARD
129 concord road, bldg. 3
billerica MA 01821
Manufacturer (Section D)
BARD ENDOSCOPIC TECHNOLOGIES, C.R. BARD
129 concord road, bldg. 3
billerica MA 01821
Manufacturer (Section G)
C.R. BARD, INC. (BIP/MENTOR)
6091 heisley rd.
mentor OH 44060
Manufacturer Contact
nancy cutino
129 concord road bldg #3
billerica , MA 01821
(978) 663 -8989
Device Event Key482193
MDR Report Key493487
Event Key467859
Report Number1223688-2003-00061
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type User facility,Other
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/17/2003,09/30/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number61 000150
Device Catalogue Number61 000150
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/06/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/29/2003
Device Ageunknown
Event Location Outpatient DIAGNOSTIC Facility
Date Manufacturer Received09/30/2003
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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