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

Model Number	24706
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation at 14 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
Additional Manufacturer Narrative
B5: updated event description.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 and was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation at 14 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.It was further reported that the target lesion was located in the severely tortuous and severely calcified anterior tibial artery.The balloon was inflated 2-3 times at 14 atmospheres and was completely removed.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation at 14 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
Additional Manufacturer Narrative
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 and was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.

• 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: 13552410
• Report Number: 2134265-2022-01810
• Device Sequence Number: 20150903
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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: 10/07/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0028166245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 03/18/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/10/2022; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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