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

Model Number	24706
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became entrapped on the guidewire.The severely calcified and mildly tortuous target lesion was located in the superficial femoral artery.A 2.4mm jetstream xc catheter was selected for use in the procedure; however, when advancing the catheter, it was unable to advance over the.014 inch thruway guidewire.They attempted to re-prime and rex the catheter but were unsuccessful.They replaced the thruway guidewire and continued to have difficulty advancing the jetstream, so the jetstream xc catheter was removed.Damage to the catheter was noted and the guidewire had kinked in multiple locations, so the jetstream xc catheter was replaced with the 2.5mm x 220mm x 150cm coyote balloon catheter in an attempt to gain further access into the vessel.The coyote balloon catheter would not advance over the thruway guidewire either, so the balloon was removed.When the balloon was removed, it appeared twisted around the wire, so both the coyote balloon catheter and the thruway guidewire were removed together.Another thruway guidewire and another jetstream catheter were used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the device became entrapped on the guidewire.The severely calcified and mildly tortuous target lesion was located in the superficial femoral artery.A 2.4mm jetstream xc catheter was selected for use in the procedure; however, when advancing the catheter, it was unable to advance over the.014 inch thruway guidewire.They attempted to re-prime and rex the catheter but were unsuccessful.They replaced the thruway guidewire and continued to have difficulty advancing the jetstream, so the jetstream xc catheter was removed.Damage to the catheter was noted and the guidewire had kinked in multiple locations, so the jetstream xc catheter was replaced with the 2.5mm x 220mm x 150cm coyote balloon catheter in an attempt to gain further access into the vessel.The coyote balloon catheter would not advance over the thruway guidewire either, so the balloon was removed.When the balloon was removed, it appeared twisted around the wire, so both the coyote balloon catheter and the thruway guidewire were removed together.Another thruway guidewire and another jetstream catheter were used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device analysis by manufacturer: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The batch number was confirmed correct.The device was received with the thruway guidewire still inserted.Multiple kinks were noted on the shaft.Buckling occurred at the balloon 15.8 cm and 19.0 cm from the tip.It was not possible to remove the guidewire due to the kinks and buckling.The balloon showed no signs of twisting but was buckled.The tip showed damage consistent with use.Device analysis was able to confirm the reported complaints.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14411891
• Report Number: 2134265-2022-05480
• Device Sequence Number: 17541010
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 10/19/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0028234461
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown