FDA Adverse Event Malfunction Summary report: N

STERLING¿

MDR report key: 2850056 · Received November 29, 2012

Report

Report Number: 2134265-2012-07321
Event Type: Malfunction
Date Received: November 29, 2012
Date of Event: November 1, 2012
Report Date: November 1, 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

(B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED. 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 DURING A PERIPHERAL ARTERY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, PROGRESSIVE, TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 7.0 X 20/135 STERLING WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE FOR 30 SECONDS AND THEN RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STERLING¿	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - MAPLE GROVE	H74939031702010	14417493

Patients

Seq	Age	Sex	Outcome	Treatment
1