FDA Adverse Event Malfunction Summary report: N

STERLING OVER-THE-WIRE

MDR report key: 1040637 · Received May 8, 2008

Report

Report Number: 2134265-2008-01340
Event Type: Malfunction
Date Received: May 8, 2008
Date of Event: April 14, 2008
Report Date: April 14, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: DQY
PMA / PMN Number: K053116
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. A 6.0 X 40/80 (4F) STERLING OTW BALLOON WAS USED TO TREAT THE 90% STENOSED LESION WITH SEVERE TORTUOUSITY AND CALCIFICATION IN THE "ANASTOMOTIC STRICTURE OF VEIN SIDE IN THE SYNTHETIC GRAFT". ON THE FIRST AND SECOND INFLATIONS, THE BALLOON WAS INFLATED TO 10 ATMOSPHERES. ON THE THIRD INFLATION THE BALLOON WAS INFLATED TO 10 ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED INTACT. THE BALLOON WAS VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (STERLING 5.0MM X 40MM). THE PT STATUS IS LISTED AS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STERLING OVER-THE-WIRE	DQY CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC CORPORATION	NA	11013273

Patients

Seq	Age	Sex	Outcome	Treatment
1	18 YR			INFLATION DEVICE: ENCORE26"\| INTRODUCER SHEATH: 4F MOSQUITO SHEATH\| GUIDEWIRE: TRANSEND EX