MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939135404010

Device Problems Failure to Advance (2524); Catheter (3038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  Malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a coyote es balloon catheter. The balloon was loosely folded with blood in the lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The tip is damaged. There is a 21mm longitudinal balloon tear 18mm from the proximal markerband. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any damage or irregularities contributing to the damage and reported crossing difficulty. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018. It was reported that crossing difficulties were encountered. The target lesion was located in the superficial femoral artery. A 4mm x 40mm x 146cm coyote es balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a different device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed balloon torn longitudinally.

• Brand Name: COYOTE¿ ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7787131
• MDR Text Key: 117291526
• Report Number: 2134265-2018-07314
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/27/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 08/15/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: H74939135404010
• Device Catalogue Number: 39135-40401
• Device LOT Number: 22020613
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/21/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial