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

Model Number	24705
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained the via the right femoral artery.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified right anterior tibial artery.After inserting a non-boston scientific (bsc) introducer sheath, a non-bsc guidewire was used to cross the lesion.A 2.5mm x 150mm x 150cm, otw coyote balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 10 seconds, the balloon ruptured and a pinhole was noted in the middle part.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient was in good condition post procedure.
Additional Manufacturer Narrative
E1- initial reporter city: (b)(6).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 8mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained the via the right femoral artery.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified right anterior tibial artery.After inserting a non-boston scientific (bsc) introducer sheath, a non-bsc guidewire was used to cross the lesion.A 2.5mm x 150mm x 150cm, otw coyote balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 10 seconds, the balloon ruptured and a pinhole was noted in the middle part.The device was removed and the procedure was completed with another of same device.No patient 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14287126
• Report Number: 2134265-2022-05183
• Device Sequence Number: 1559712
• Product Code: DQY
• UDI-Device Identifier: 08714729796534
• UDI-Public: 08714729796534
• 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): 06/10/2022

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: 01/26/2025
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0028756393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 06/04/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: GUIDEWIRE: JUPITER NS15; GUIDEWIRE: JUPITER NS15; INFLATION DEVICE: EVEREST; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: HELLO ONE 5F; INTRODUCER SHEATH: HELLO ONE 5F; MICRO CATHETER: CORSIR PV; MICRO CATHETER: CORSIR PV
• Patient Sex: Unknown