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

Model Number	24705
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in superficial femoral artery.A 4.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation, it was noted that the balloon show signs of crimping and it was stuck to the wire.The procedure was completed and there were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon catheter with a 0.014" guidewire stuck inside of it.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 4cm and 6.5cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the reported event.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the superficial femoral artery.A 4.0mm x 150mm x 150cm coyote balloon catheter was advanded for dilation.However, during procedure, it was noted that the balloon show signs of crimping and it stuck to the wire.The procedure was completed and there were no patient complications nor injuries reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12306898
• Report Number: 2134265-2021-10107
• Device Sequence Number: 19750668
• Product Code: DQY
• UDI-Device Identifier: 08714729796664
• UDI-Public: 08714729796664
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0026475262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1