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Adverse Event Report

CORDIS CORPORATION CORDIS DIAGNOSTIC CATHETER   back to search results
Model Number JR4 CORONARY CATHETER
Device Problems Device breakage; Tube(s), defective
Event Date 05/19/1998
Patient Outcome  Required Intervention;
Event Description

Catheter knotted during invivo manipulation. During physician's efforts to detangle and remove, catheter broke while in the pt. Surgery required to repair artery and pt discharged on 5/23/98.

 
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Brand NameCORDIS
Type of DeviceDIAGNOSTIC CATHETER
Baseline Brand NameCORDIS DIAGNOSTIC CATHETER
Baseline Generic NameDIAGNOSTIC CATHETER
Baseline Catalogue Number532-621
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CORDIS CORPORATION
14201 n.w. 60th ave
miami lakes FL 33014
Manufacturer (Section D)
CORDIS CORPORATION
po box 52500
miami FL 33137
Device Event Key170424
MDR Report Key175276
Event Key164740
Report Number175276
Device Sequence Number1
Product CodeDQO
Report Source User Facility
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 05/26/1998,05/28/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberJR4 CORONARY CATHETER
Device Catalogue Number532-621
Device LOT NumberL0398727
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/20/1998
Event Location Hospital
Date Report TO Manufacturer05/28/1998
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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