FDA Adverse Event Malfunction Summary report: N

STERLING BALLOON DILATATION CATHETER

MDR report key: 1944261 · Received January 3, 2011

Report

Report Number: 2134265-2010-05795
Event Type: Malfunction
Date Received: January 3, 2011
Date of Event: December 13, 2010
Report Date: December 15, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DQY
PMA / PMN Number: K053118
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. A 6FR 10CM INTRODUCER SHEATH WAS INSERTED AND A 0.014 175CM GUIDE WIRE WAS ADVANCED. NEXT THE PHYSICIAN ADVANCED THE 5MM X 40MM X 135CM STERLING BALLOON CATHETER ACROSS THE LESION, INFLATED THE BALLOON ONCE TO 6 ATMS, AND THE BALLOON RUPTURED. 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 BALLOON DILATATION CATHETER	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - MAPLE GROVE	H74939031504010	13705842

Patients

Seq	Age	Sex	Outcome	Treatment
1				INTRODUCER SHEATH: 6F 10CM TERUMO\| INFLATION DEVICE: MEDTRONIC\| GUIDE WIRE: 0.014 CRUISE 175CM SJM