FDA Adverse Event Malfunction Summary report: N

MUSTANG¿

MDR report key: 3042224 · Received April 9, 2013

Report

Report Number: 2134265-2013-02085
Event Type: Malfunction
Date Received: April 9, 2013
Date of Event: March 8, 2013
Report Date: March 11, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: LIT
PMA / PMN Number: K103751
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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. USING A RIGHT EXTERNAL ILIAC ARTERY APPROACH, THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERLY CALCIFIED EXTERNAL ILIAC ARTERY. USING A NON-BSC GUIDEWIRE AND GUIDING SHEATH, THE 5.0 X 20MM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE LESION WHEN IT RUPTURED AT 24 ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PHYSICIAN PLACED A NON-BSC STENT AND POST-DILATED WITH A 8.0 × 20MM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
145232	MUSTANG¿	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - GALWAY	H74939171050270	0015468500

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDEWIRE: RADIFOCUS (TERUMO)\| GUIDING SHEATH: 6FR 45CM DESTINATION (TERUMO)