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 Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of aware date as there was no date provided.
Event or Problem Description
It was reported that catheter entrapment occurred.A 3.0mm x 220mm x 150cm coyote balloon catheter was selected for use.However, it was noted that the balloon had difficulties advancing on the wire and was described to be stiff.The balloon could not move and was subsequently stuck on the wire.The balloon and the wire were removed together and no known patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment occurred.A 3.0mm x 220mm x 150cm coyote balloon catheter was selected for use.However, it was noted that the balloon had difficulties advancing on the wire and was described to be stiff.The balloon could not move and was subsequently stuck on the wire.The balloon and the wire were removed together and no known patient complications were reported.It was further reported that the target lesion was located in the tibial artery and the procedure was completed with a new balloon and wire.
Additional Manufacturer Narrative
B3 date of event updated.B5 describe event or problem updated.
Event or Problem Description
It was reported that catheter entrapment occurred.A 3.0mm x 220mm x 150cm coyote balloon catheter was selected for use.However, it was noted that the balloon had difficulties advancing on the wire and was described to be stiff.The balloon could not move and was subsequently stuck on the wire.The balloon and the wire were removed together and no known patient complications were reported.It was further reported that the target lesion was located in the tibial artery and the procedure was completed with a new balloon and wire.
Additional Manufacturer Narrative
B3 date of event updated.B5 describe event or problem updated.Device evaluated by mfr.:returned product consisted of a coyote balloon catheter with a non-bsc.014 guidewire in the lumen.The hub, shafts, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon and blood in the guidewire lumen.The balloon was loosely folded.Inspection of the device revealed that the wire lumen shaft was buckled in the hub and extending down into the shaft for 3mm.The guidewire used in the procedure was received stuck inside the complaint device.An attempt to remove the guidewire was unsuccessful, as it was stuck on wire due to the buckled wire lumen shaft.The damage to the wire lumen shaft is consistent to damage caused by the guidewire during advancement or removal.

• 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: 9528930
• Report Number: 2134265-2019-16261
• Device Sequence Number: 14037186
• Product Code: DQY
• UDI-Device Identifier: 08714729797265
• UDI-Public: 08714729797265
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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: 09/11/2022
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0024420937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/05/2020; 02/13/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/22/2020; 03/03/2020
• 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: WIRE:ABBOTT COMMAND; WIRE:ABBOTT COMMAND; WIRE:ABBOTT COMMAND