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

Model Number 24691

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported that the catheter froze on wire.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral and popliteal artery.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation; however, it got stuck with a.014 300cm non-bsc guidewire.The catheter and the guidewire were removed as a single unit and the procedure was completed with a different device.There were no complications nor injuries reported.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluation by mfr: returned product consisted of a coyote es balloon catheter with a 0.014 guidewire stuck inside the distal separated section.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple buckling to the guidewire lumen and inflation lumen.The inflation lumen is separated 125.5cm from the hub.The inflation lumen is stretched at both ends of the separation.The hypotube is kinked 19cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the catheter froze on wire.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral and popliteal artery.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation; however, it got stuck with a.014 300cm non-bsc guidewire.The catheter and the guidewire were removed as a single unit and the procedure was completed with a different device.There were no complications nor injuries reported.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13549009
• MDR Text Key: 285741645
• Report Number: 2134265-2022-01326
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: 08714729767190
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0028091493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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