FDA Adverse Event Injury Summary report: N

ZIPWIRE HYDROPHILIC GUIDE WIRE

MDR report key: 1833779 · Received September 14, 2010

Report

Report Number: 2134265-2010-04169
Event Type: Injury
Date Received: September 14, 2010
Report Date: August 26, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DQX
PMA / PMN Number: K000011
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR #: 2134265-2010-04168, 2134265-2010-04170, 2134265-2010-04171, 2134265-2010-04172. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE THE GUIDE WIRE COATING PEELED OFF THE DEVICE. THE LESION LOCATION AND LESION CHARACTERISTICS ARE UNKNOWN. THREE OF THE FIVE ZIPWIRE HYDROPHILIC GUIDE WIRES WERE INTRODUCED INTO THE PATIENT AND THE PHYSICIAN NOTED THAT THE GUIDE WIRE COATING PEELED OFF EACH DEVICE DURING THE PROCEDURE. IT IS UNKNOWN IF ANY OF THE PEELED COATING DETACHED INSIDE THE PATIENT. DURING PREPARATION OF THE REMAINING 2 ZIPWIRES, THE PHYSICIAN NOTED THAT THE COATING WAS PEELING AND DID NOT USE THESE TWO WIRES INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZIPWIRE HYDROPHILIC GUIDE WIRE	WIRE, GUIDE, CATHETER	DQX	BOSTON SCIENTIFIC - MAPLE GROVE	M00146156B1	0001417252

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other