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

Model Number	24705
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon failed to deflate.The 50% stenosed, which was approximately 2.5 cm x 100 mm in size, soft and straight target lesion was located in the mildly tortuous and mildly calcified distal superficial femoral artery (sfa) extending to the popliteal artery.A 3.0mm x 150mm x 150cm coyote balloon was advanced for dilation.However, during first inflation at 6 atmospheres, the balloon appeared to inflate in certain areas but failed to inflate in others.An attempt was made to deflate the balloon for 5 minutes, but the angiogram showed that it was not deflating.The physician used a 60-cc syringe to pull negative pressure to the balloon, which resulted in minimal deflation.The device was removed intact, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a twist 9.5cm, 12cm, and 15cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that would have contributed to the reported difficulty to deflate and inflate.
Event or Problem Description
It was reported that the balloon failed to deflate.The 50% stenosed, which was approximately 2.5 cm x 100 mm in size, soft and straight target lesion was located in the mildly tortuous and mildly calcified distal superficial femoral artery (sfa) extending to the popliteal artery.A 3.0mm x 150mm x 150cm coyote balloon was advanced for dilation.However, during first inflation at 6 atmospheres, the balloon appeared to inflate in certain areas but failed to inflate in others.An attempt was made to deflate the balloon for 5 minutes, but the angiogram showed that it was not deflating.The physician used a 60-cc syringe to pull negative pressure to the balloon, which resulted in minimal deflation.The device was removed intact, and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20043329
• Report Number: 2124215-2024-51203
• Device Sequence Number: 7933786
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/20/2024

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 Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0033629238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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