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	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target 70% stenosed target lesion was located in the severely tortuous and severely calcified dorsalis pedis artery.A 1.5mm x 40mm x 150cm, otw coyote balloon catheter was advanced for dilation.However, during second inflation at 14 atmospheres for 10 minutes, the balloon burst.The procedure was cancelled/rescheduled.There were no patient complications nor injuries reported and the patient condition was good.
Event or Problem Description
It was reported that balloon rupture occurred.The target 70% stenosed target lesion was located in the severely tortuous and severely calcified dorsalis pedis artery.A 1.5mm x 40mm x 150cm, otw coyote balloon catheter was advanced for dilation.However, during second inflation at 14 atmospheres for 10 minutes, the balloon burst.The procedure was cancelled/rescheduled.There were no patient complications nor injuries reported and the patient condition was good.
Additional Manufacturer Narrative
Returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The batch number was confirmed correct.Microscopic analysis confirmed a pinhole 4 cm from the distal end of the balloon.Device analysis was able to confirm the reported complaint of a material rupture.
Event or Problem Description
It was reported that balloon rupture occurred.The target 70% stenosed target lesion was located in the severely tortuous and severely calcified dorsalis pedis artery.A 1.5mm x 40mm x 150cm, otw coyote balloon catheter was advanced for dilation.However, during second inflation at 14 atmospheres for 10 minutes, the balloon burst.The procedure was cancelled/rescheduled.There were no patient complications nor injuries reported and the patient condition 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13635844
• Report Number: 2134265-2022-01682
• Device Sequence Number: 2174591
• Product Code: DQY
• UDI-Device Identifier: 08714729796411
• UDI-Public: 08714729796411
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/03/2022

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: 08/02/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0027767694
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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 Age: 67 YR
• Patient Sex: Male