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

Model Number	24704
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 2.0mm x 80mm x 90cm, otw coyote balloon dilatation catheter was selected for the index procedure.During the procedure, however, the coyote balloon dilatation catheter was advanced, but the non-boston scientific.014 inch, 190 cm guidewire became entrapped in the balloon catheter.The procedure was completed with another of same device.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: 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 no damages.Microscopic examination revealed buckling to the shaft 28cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that would have contributed to the reported event.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 2.0mm x 80mm x 90cm, otw coyote balloon dilatation catheter was selected for the index procedure.During the procedure, however, the coyote balloon dilatation catheter was advanced, but the non-boston scientific.014 inch, 190 cm guidewire became entrapped in the balloon catheter.The procedure was completed with another of same device.No patient harm resulted in relation to this event.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17587543
• Report Number: 2124215-2023-44844
• Device Sequence Number: 2395163
• Product Code: DQY
• UDI-Device Identifier: 08714729796435
• UDI-Public: 08714729796435
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 01/12/2026
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0030844804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown