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

Model Number	24701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
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 and severely calcified superficial femoral artery (sfa).A 2mm x 20mm x 142cm coyote es balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 2mm x 20mm x 142cm coyote es balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed, 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 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 showed no issues; however, the microscopic examination revealed a pinhole around 2.5cm from the tip of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon cause the rupture.

• Brand Name: COYOTE ES
• 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: 20469534
• Report Number: 2124215-2024-64954
• Device Sequence Number: 20712788
• Product Code: LIT
• UDI-Device Identifier: 08714729767336
• UDI-Public: 08714729767336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• 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): 11/04/2024

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: 05/02/2026
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0033948218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - CROSSLEAD; GUIDEWIRE - CROSSLEAD; INFLATION DEVICE - NIPRO; INFLATION DEVICE - NIPRO; INTRODUCER SHEATH - HALLO1; INTRODUCER SHEATH - HALLO1; MICRO CATHETER - PROMINENT; MICRO CATHETER - PROMINENT; STENT - SUPERA; STENT - SUPERA
• Patient Sex: Unknown