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	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified tibioperoneal trunk and posterior tibial artery.A 4.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 6 atmospheres for 1 minute, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified tibioperoneal trunk and posterior tibial artery.A 4.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 6 atmospheres for 1 minute, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The device showed signs of use.The balloon rupture was confirmed 60.3 cm from the distal tip.Dilation was noted at 6 atm for 1 minute; this is below the maximum of 14 atms.No other damage was seen.The complaint was confirmed.

• 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: 14643094
• Report Number: 2134265-2022-06601
• Device Sequence Number: 4841755
• Product Code: DQY
• UDI-Device Identifier: 08714729796671
• UDI-Public: 08714729796671
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 12/21/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0028603073
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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