FDA Adverse Event Malfunction Summary report: N

STERLING¿

MDR report key: 2914755 · Received January 14, 2013

Report

Report Number: 2134265-2012-08417
Event Type: Malfunction
Date Received: January 14, 2013
Date of Event: December 7, 2012
Report Date: December 17, 2012
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: 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 A PERIPHERAL ARTERY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE COMMON FEMORAL ARTERY. THE 90% DE NOVO LESION BEING TREATED WAS LOCATED IN A DE NOVO SEVERELY CALCIFIED, MODERATELY TORTUOUS RIGHT ILIAC ARTERY. THE 7.0X20/135 STERLING BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. THE BALLOON WAS INFLATED ONCE TO 6 ATM, AND THEN RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21577	STERLING¿	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - MAPLE GROVE	H74939031702010	15216617

Patients

Seq	Age	Sex	Outcome	Treatment
1