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

Model Number	24705
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in popliteal artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon could not be fully dilated.After it was withdrawn, liquid was injected but the balloon was leaking, and it was broken.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in popliteal artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon could not be fully dilated.After it was withdrawn, liquid was injected but the balloon was leaking, and it was broken.The procedure was completed with another of the same device.There were no patient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 severely tortuous and severely calcified with 80% stenosis.The balloon was inflated once at 14 atmospheres for 60 seconds before it was ruptured.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in popliteal artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during inflation, the balloon could not be fully dilated.After it was withdrawn, liquid was injected but the balloon was leaking, and it was broken.The procedure was completed with another of the same device.There were no patient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 severely tortuous and severely calcified with 80% stenosis.The balloon was inflated once at 14 atmospheres for 60 seconds before it was ruptured.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: 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 longitudinal tear 95mm from the tip and is approximately 3mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.

• 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: 16321914
• Report Number: 2124215-2023-05278
• Device Sequence Number: 7895425
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/15/2023

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: 06/12/2023
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0025591775
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 02/08/2023; 03/08/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/13/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 70 KG