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

Model Number	24698
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee.A 2.5mm x 150mm x 150cm, mr coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured at nominal pressure.The procedure was completed with a different device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee.A 2.5mm x 150mm x 150cm, mr coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured at nominal pressure.The procedure was completed with a different device.No patient complications nor injuries were reported.It was further reported that the balloon was ruptured during second inflation at 8 atmospheres and was completely removed from the patient.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).Updated b5: describe event or problem.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12389176
• Report Number: 2134265-2021-10978
• Device Sequence Number: 4648748
• Product Code: LIT
• UDI-Device Identifier: 08714729796886
• UDI-Public: 08714729796886
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 04/29/2023
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0025479437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1