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

Model Number	24706
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issue occurred.A 4.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.During inflation.A portion of the balloon had inflated, then it looked like it was just wire, and then a little portion inflated.Upon checking, a segment of the balloon is twisted, and one segment of the balloon would not deflate properly.The balloon was pulled back within the vessel and the pressure of pulling it in the vessel was enough to deflate the remainder.The balloon was removed from the patient.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a twist 5cm from the tip.Microscopic examination revealed no additional damages.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon deflation issue occurred.A 4.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.During inflation.A portion of the balloon had inflated, then it looked like it was just wire, and then a little portion inflated.Upon checking, a segment of the balloon is twisted, and one segment of the balloon would not deflate properly.The balloon was pulled back within the vessel and the pressure of pulling it in the vessel was enough to deflate the remainder.The balloon was removed from the patient.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: 20347160
• Report Number: 2124215-2024-58660
• Device Sequence Number: 18169684
• Product Code: DQY
• UDI-Device Identifier: 08714729796671
• UDI-Public: 08714729796671
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/01/2024

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: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0034126731
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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