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 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.The balloon was loosely folded with blood in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.There are numerous hypotube and shaft kinks.The tip is damaged.Microscopic examination revealed that the balloon has a 11mm longitudinal tear starting at the proximal markerband.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 20-dec-2018.It was reported that crossing difficulties were encountered.The target lesion was located in the superficial femoral artery.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation but the device failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a balloon tear.

• 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: 8240047
• MDR Text Key: 132813706
• Report Number: 2134265-2018-65038
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: 08714729767176
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0022748956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• 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