FDA Adverse Event Malfunction Summary report: N

STERLING?

MDR report key: 3963642 · Received July 29, 2014

Report

Report Number: 2134265-2014-04399
Event Type: Malfunction
Date Received: July 29, 2014
Date of Event: July 2, 2014
Report Date: July 2, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DQY
PMA / PMN Number: K053116
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 MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 THE BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING THE INTRODUCTION OF A 6FRX55CM NON-BSC INTRODUCER SHEATH AND A 0.014X300 NON-BSC GUIDE WIRE, A 6.0MMX100MMX80CM-HYBRID STERLING¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. INITIALLY, THE BALLOON WAS INFLATED AT 10 ATMOSPHERES. HOWEVER, UPON THE SECOND INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE BALLOON WAS COMPLETELY RETRIEVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH A 6X100 MUSTANG¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
442570	STERLING?	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - MAPLE GROVE	H74939032601080	16108063

Patients

Seq	Age	Sex	Outcome	Treatment
1				AGURU SUPPORT/0.014X300/BSJ- GUIDE WIRE\| ACCELE/6FRX55CM/COOK- INTRODUCER SHEATH