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	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire occurred.The patient presented with peripheral artery disease (pad).The 80% stenosed target lesion was located in the non-tortuous and calcified tibial vessel.Following crossing of a platinum plus guidewire in the lesion, a 2.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation and was inflated at 8 atmospheres for 2 minutes.The balloon was then fully deflated, however, the device became stuck on the wire.The physician tried to advance the balloon after deflation to loosen it from the wire.Eventually, both devices were removed intact as a unit.The physician then rewired with another platinum plus guidewire, and intravascular ultrasound (ivus) was performed.No further treatment was needed after ivus and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter with a guidewire approximately 300cm stuck inside of it.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is stretched.Microscopic examination revealed no additional damages.The guidewire was pulled lightly but it does not appear to be moving so the guidewire was left inside the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the reported event.
Event or Problem Description
It was reported that froze on wire occurred.The patient presented with peripheral artery disease (pad).The 80% stenosed target lesion was located in the non-tortuous and calcified tibial vessel.Following crossing of a platinum plus guidewire in the lesion, a 2.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation and was inflated at 8 atmospheres for 2 minutes.The balloon was then fully deflated, however, the device became stuck on the wire.The physician tried to advance the balloon after deflation to loosen it from the wire.Eventually, both devices were removed intact as a unit.The physician then rewired with another platinum plus guidewire, and intravascular ultrasound (ivus) was performed.No further treatment was needed after ivus and the procedure was completed.There were no patient complications reported.

• 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: 14402375
• Report Number: 2134265-2022-05038
• Device Sequence Number: 20218286
• Product Code: DQY
• UDI-Device Identifier: 08714729797135
• UDI-Public: 08714729797135
• 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: Physician
• 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: 12/05/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0028506541
• 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: 05/18/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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