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 Consequences Or Impact To Patient (2199)
Date of Event	09/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, the non-bsc guidewire became stuck within the device and the whole system was removed.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, the non-bsc guidewire became stuck within the device and the whole system was removed.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen, and blood in the guidewire lumen.The inner shaft was buckled for 36cm starting at the distal marker band and extending proximally.The inner shaft was separated from the manifold.The balloon had a circumferential tear starting 1mm proximal of the distal marker band.The balloon was buckled for 11mm.The outer shaft was stretched down for 5mm.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 10632270
• Report Number: 2134265-2020-12954
• Device Sequence Number: 3650143
• Product Code: DQY
• UDI-Device Identifier: 08714729796459
• UDI-Public: 08714729796459
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 06/19/2023
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0025618064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: ASTATO 9-40 ASAHI INTECC; GUIDEWIRE: ASTATO 9-40 ASAHI INTECC