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

Model Number H74939135204010

Device Problems Failure to Advance; Catheter

Event Date 07/10/2018

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. Te outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. The balloon has a pinhole at the distal markerband. Inspection of the remainder of the device presented no other damage or irregularities. The investigation conclusion is operational context as the product meets the design & 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 10-aug-2018. It was reported that crossing difficulties were encountered. The target lesion was located in the superficial femoral artery. A 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced for pre-dilatation. However, the device failed to cross the lesion despite several attempts. The procedure was completed with a non-bsc device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed balloon pinhole.

• 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: 7851370
• Report Number: 2134265-2018-07384
• Device Sequence Number: 1
• Product Code: LIT
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/10/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/06/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: H74939135204010
• Device Catalogue Number: 39135-20401
• Device LOT Number: 21832063
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial