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

Model Number	24699
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous superficial femoral artery.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during second inflation at 14 atmospheres for 20 seconds, the balloon ruptured vertically.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the returned piece is the midsection of the balloon catheter.The returned piece measures approximately 91.7cm from the inflation lumen to the separated balloon.The guidewire lumen is separated approximately 48.7cm from the exit notch and appears to be stretched.There are multiple kinks to the guidewire lumen.Microscopic examination revealed no additional damages.The missing parts are the hub, proximal section of the inflation lumen, distal end of the balloon, distal end of the guidewire lumen, tip, and markerband.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous superficial femoral artery.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during second inflation at 14 atmospheres for 20 seconds, the balloon ruptured vertically.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post procedure.

• 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: 19601085
• Report Number: 2124215-2024-38141
• Device Sequence Number: 12813143
• Product Code: DQY
• UDI-Device Identifier: 08714729796893
• UDI-Public: 08714729796893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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 Expiration Date: 12/13/2024
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0028553082
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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