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

Model Number	24704
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for percutaneous transluminal angioplasty.The 85% stenosed target lesion was located in the non-tortuous and severely calcified vessel.A 1.5mm x 40mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon burst before reaching the nominal pressure.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for percutaneous transluminal angioplasty.The 85% stenosed target lesion was located in the non-tortuous and severely calcified vessel.A 1.5mm x 40mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon burst before reaching the nominal pressure.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.It was further reported that the target lesion was peripheral artery.Also, the balloon ruptured on first inflation and all the segments of the balloon were removed from the patient carefully and slowly.
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.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 and microscopic examination revealed no damages.The balloon was inflated to rated burst pressure (rbp) and was able to hold pressure.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 patient presented for percutaneous transluminal angioplasty.The 85% stenosed target lesion was located in the non-tortuous and severely calcified vessel.A 1.5mm x 40mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon burst before reaching the nominal pressure.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.It was further reported that the target lesion was peripheral artery.Also, the balloon ruptured on first inflation and all the segments of the balloon were removed from the patient carefully and slowly.

• 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: 15772243
• Report Number: 2124215-2022-46519
• Device Sequence Number: 17386539
• Product Code: DQY
• UDI-Device Identifier: 08714729796411
• UDI-Public: 08714729796411
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 12/16/2022

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: 12/14/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0028560744
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 11/11/2022; 12/12/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 11/16/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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