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	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 100% stenosed target lesion was located in the moderately tortuous and mildly calcified left superficial femoral artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.The balloon was initially inflated at 8 atmospheres (atm) for 30 seconds.However, during second inflation at 10 atm for 30 seconds, the balloon ruptured.The device was removed and a pinhole at the middle part of the balloon was found.The procedure was completed with another of same device.No patient complications nor injuries were reported and the patient status was good.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter city: (b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 35mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.(a2) age at time of event: 18 years or older.(e1) initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 100% stenosed target lesion was located in the moderately tortuous and mildly calcified left superficial femoral artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.The balloon was initially inflated at 8 atmospheres (atm) for 30 seconds.However, during second inflation at 10 atm for 30 seconds, the balloon ruptured.The device was removed and a pinhole at the middle part of the balloon was found.The procedure was completed with another of same device.No patient complications nor injuries were reported and the patient status was good.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15451319
• Report Number: 2124215-2022-36490
• Device Sequence Number: 6070881
• Product Code: LIT
• UDI-Device Identifier: 08714729796961
• UDI-Public: 08714729796961
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 02/10/2025
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0028851144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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: GUIDE CATHETER: MACH 1/6FR.; GUIDE CATHETER: MACH 1/6FR.; GUIDEWIRE: JUPITER.; GUIDEWIRE: JUPITER.; INFLATION DEVICE:GM30.; INFLATION DEVICE:GM30.; INTRODUCER SHEATH: PARENT 5082.; INTRODUCER SHEATH: PARENT 5082.
• Patient Sex: Female