FDA Adverse Event Malfunction Summary report: N

STERLING BALLOON DILATATION CATHETER

MDR report key: 1900896 · Received November 17, 2010

Report

Report Number: 2134265-2010-05075
Event Type: Malfunction
Date Received: November 17, 2010
Date of Event: October 28, 2010
Report Date: October 28, 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

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED 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. VASCULAR ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY WITH A CONTRALATERAL APPROACH. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY (CIA). THIS 6.0 X 20/135 (4F) STERLING BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 14 ATMS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. 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	H74939031602010	13402209

Patients

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