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

Model Number	24706
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties occurred.The patient presented with peripheral artery disease (pad).The 90% stenosed target lesion was located in the moderately calcified anterior tibial artery.Following atherectomy and pre-dilatation, residual stenosis was 30-40%.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.The device was inflated at nominal pressure and was deflated without issue.However, it was noted that the balloon was difficult to remove but eventually removed without issue.The coyote balloon catheter was re-introduced but it would not even load on the wire.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Event or Problem Description
It was reported that removal difficulties occurred.The patient presented with peripheral artery disease (pad).The 90% stenosed target lesion was located in the moderately calcified anterior tibial artery.Following atherectomy and pre-dilatation, residual stenosis was 30-40%.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.The device was inflated at nominal pressure and was deflated without issue.However, it was noted that the balloon was difficult to remove but eventually removed without issue.The coyote balloon catheter was re-introduced but it would not even load on the wire.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The batch lot was confirmed correct.Microscopic analysis confirmed kinks under the balloon 22.1 mm and 21.7 mm from the tip.When a guidewire was back loaded into the device it stopped 21.1 mm from the tip due to the kink.Removal of the guidewire had resistance.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: 14282572
• Report Number: 2134265-2022-04599
• Device Sequence Number: 17823791
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: 08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 01/10/2025
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0028661311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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