MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 24691

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

Reportable based on device analysis complete on 09 nov 2018.It was reported that crossing difficulties were encountered.The stenosed target lesion was located in the below the knee (btk).An unknown guidewire was advanced to the target lesion and pre-dilated with 2.5mm x 40mm x 146cm coyote es balloon catheter with a combination of an unknown guidezilla 2 pv guide extension catheter as a back up to strengthen the balloon but still failed to cross the lesion.The procedure was completed with a non bsc product.No patient serious injury or adverse event were reported.However, returned device analysis revealed balloon pinhole.The outer shaft, inner shaft, balloon and tip were microscopically examined.There are numerous hypotube and shaft kinks.The inner shaft is buckled in numerous locations.Microscopic examination revealed that the balloon has a pinhole at the distal markerband.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8126712
• MDR Text Key: 129154798
• Report Number: 2134265-2018-63484
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767220
• UDI-Public: 08714729767220
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0021973783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1