FDA Adverse Event Malfunction Summary report: N

STERLING ES PTA BALLOON DILATATION CATHETER

MDR report key: 2213314 · Received August 16, 2011

Report

Report Number: 2134265-2011-03396
Event Type: Malfunction
Date Received: August 16, 2011
Date of Event: July 26, 2011
Report Date: July 26, 2011
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LIT
PMA / PMN Number: K080982
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE INGUINAL REGION. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED POPLITEAL ARTERY. A 1.5MM X 20MM X 142CM STERLING ES BALLOON CATHETER WAS SELECTED FOR PRE-DILATION AND WAS ADVANCED TO THE LESION. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STERLING ES PTA BALLOON DILATATION CATHETER	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - MAPLE GROVE	H74939134152010	14134909

Patients

Seq	Age	Sex	Outcome	Treatment
1				INTRODUCER SHEATH: TERUMO 6F\| GUIDE WIRE: CRUISE