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Adverse Event Report

COOK INCORPORATED TFE COATED STRAIGHT WIRE GUIDE   back to search results
Catalog Number TSF-35-125-BH
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The wire was being utilized to perform a ct-guided abscess drainage on a pt with a diverticular abscess. The wire insertion and dilatation of the tract went well. However, following placement of a 10 fr. Apd catheter, the wire was unable to be removed and sheared off. The pt was taken to surgery for treatment of diverticular abscess and removal of wire guide abscess and removal of wire guide segment from the peritoneal cavity.

 
Manufacturer Narrative

A. 1,2,4) info not available b. 3) info not available f. 6) info not available h. 6) method-device was not returned for evaluation. No product was returned to assist in co's evaluation of this matter. A review of mfg records found no other reports of problems associated with this lot number. Unfortunately, from the available info, co is unable to determine why this event may have occurred. Co can advise this device is inspected 100% in quality control prior to shipping.

 
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Brand NameTFE COATED STRAIGHT WIRE GUIDE
Type of DeviceWIRE GUIDE
Baseline Brand NameTFE COATED STRAIGHT WIRE GUIDE
Baseline Generic NameNA
Baseline Catalogue NumberTSF-35-125-BH
Baseline Device FamilyWIRE GUIDE
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Manufacturer (Section F)
COOK INCORPORATED
925 south curry pike
bloomington IN 47402
Manufacturer (Section D)
COOK INCORPORATED
925 south curry pike
bloomington IN 47402
Manufacturer (Section G)
COOK, INC.
750 daniels way po bx 489
bloomington IN 47402
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
(812) 339 -2235 ext 2222
Device Event Key123706
MDR Report Key126395
Event Key118852
Report Number1820334-1997-00143
Device Sequence Number1
Product CodeDQX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/19/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/11/2000
Device Catalogue NumberTSF-35-125-BH
Device LOT Number557580
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age2 yr
Event Location Hospital
Date Manufacturer Received09/19/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/1995
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 January 30, 2009

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