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	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior tibial artery.A 3.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the first inflation at 7 atmospheres, the balloon ruptured.After a 1.75mm rotablation was performed and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
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 39mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior tibial artery.A 3.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the first inflation at 7 atmospheres, the balloon ruptured.After a 1.75mm rotablation was performed and the procedure was completed.No patient complications were reported.

• 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: 15272454
• Report Number: 2124215-2022-31886
• Device Sequence Number: 14922734
• Product Code: DQY
• UDI-Device Identifier: 08714729797326
• UDI-Public: 08714729797326
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/21/2022

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: 12/15/2023
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0026520045
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG