FDA Adverse Event Malfunction Summary report: N

STERLING ES PTA BALLOON DILATATION CATHETER

MDR report key: 1833071 · Received September 14, 2010

Report

Report Number: 2134265-2010-04029
Event Type: Malfunction
Date Received: September 14, 2010
Date of Event: August 25, 2010
Report Date: August 25, 2010
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

(B)(4). THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% RESTENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT RADIAL ARTERY. THE PHYSICIAN ADVANCED THE 3.0MMX40MMX145CM STERLING BALLOON TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 10ATMS. ON THE SECOND INFLATION THE BALLOON WAS INFLATED TO 12ATMS FOR APPROXIMATELY TEN SECONDS AND RUPTURED. THE DEVICE WAS REMOVED INTACT. NO COMPLICATIONS WERE REPORTED AND PATIENT 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	H74939134304010	12270212

Patients

Seq	Age	Sex	Outcome	Treatment
1				EVEREST INFLATION UNIT\| RUNTHROUGH PERI GUIDE WIRE\| 4F MEDIIKIT INTRODUCER SHEATH