FDA Adverse Event Malfunction Summary report: N

COYOTE?

MDR report key: 3963674 · Received July 29, 2014

Report

Report Number: 2134265-2014-04400
Event Type: Malfunction
Date Received: July 29, 2014
Date of Event: July 3, 2014
Report Date: July 3, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LIT
PMA / PMN Number: K111295
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.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS RIGHT PERONEAL ARTERY. AFTER AN UNSPECIFIED GUIDEWIRE CROSSED THE LESION, A 2.0MM X 220MM X 150CM COYOTE¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. BEFORE REACHING THE TARGET LESION THE BALLOON DILATED THE ANTERIOR TIBIAL ARTERY TWICE AT UNSPECIFIED PRESSURE. AFTER REACHING THE TARGET LESION THE BALLOON WAS INFLATED TO 8 ATMOSPHERES AND RUPTURED ON THE FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE SHEATH AND THE PROCEDURE WAS NOT COMPLETED BECAUSE OF THE UNAVAILABILITY OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
442336	COYOTE?	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - MAPLE GROVE	H74939185202210	16941703

Patients

Seq	Age	Sex	Outcome	Treatment
1