FDA Adverse Event Malfunction Summary report: N

STERLING¿

MDR report key: 3030186 · Received April 2, 2013

Report

Report Number: 2134265-2013-02508
Event Type: Malfunction
Date Received: April 2, 2013
Date of Event: March 5, 2013
Report Date: March 5, 2013
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 MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN ENDOVASCULAR THERAPY PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT COMMON FEMORAL ARTERY. A NON BSC GUIDE WIRE CROSSED THE LESION AND AN UNSPECIFIED MICROCATHETER WAS UNABLE TO CROSS THE LESION. THE 3.0 X 20MM STERLING MR BALLOON CATHETER WAS ADVANCED AGAINST STRONG RESISTANCE, BUT WAS ABLE TO CROSS THE LESION. THE BALLOON WAS INFLATED AND RUPTURED AS PRESSURE RAPIDLY DECREASED AND BLOOD FLOW WAS FOUND IN THE CATHETER. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
133530	STERLING¿	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - MAPLE GROVE	H74939031302010	15217938

Patients

Seq	Age	Sex	Outcome	Treatment
1				AGURU: GUIDE WIRE\| 6F MEDIKIT: INTRODUCER SHEATH\| ASTATO: GUIDE WIRE