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

Model Number	24706
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that device entrapment occurred.A 2.5mm x 220mm x 150cm, otw coyote balloon catheter was selected for use; however, a non-bsc guidewire was stuck on the balloon catheter.The device was completely removed as a whole and no known patient complications were reported.
Additional Manufacturer Narrative
B3 date of event corrected.The device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed that the guidewire lumen was prolapsed and there was a hole.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that device entrapment occurred.A 2.5mm x 220mm x 150cm, otw coyote balloon catheter was selected for use; however, a non-bsc guidewire was stuck on the balloon catheter.The device was completely removed as a whole and no known patient complications were reported.It was further reported that the 60% stenosed target lesion was located in the mildly calcified and non-tortuous anterior tibial artery.The procedure was completed with another device and the patient condition was fine.

• 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: 11497073
• Report Number: 2134265-2021-02925
• Device Sequence Number: 5373978
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 01/19/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0026654907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: GLADIUS MONGO.; GUIDEWIRE: GLADIUS MONGO.; GUIDEWIRE: GLADIUS MONGO