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	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the posterior tibial artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon would not inflate when it was injected with contrast medium into the pressure pump.The device was removed, and it was confirmed that the balloon was leaking liquid and had a tear.The procedure was completed using another of the same device.No complications reported, and patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the posterior tibial artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon would not inflate when it was injected with contrast medium into the pressure pump.The device was removed, and it was confirmed that the balloon was leaking liquid and had a tear.The procedure was completed using another of the same device.No complications reported, and patient status was stable.It was further reported that the target lesion was about 80% stenosed, moderately tortuous, and severely calcified.The balloon was not inflated and was at 10 atmospheres for 10 seconds when the problem was noted.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.The device was returned for analysis and the evaluation was completed on 01oct2024.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a circumferential tear 2.7cm from the tip.There were no other damage or irregularities.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20163794
• Report Number: 2124215-2024-55873
• Device Sequence Number: 15281890
• Product Code: DQY
• UDI-Device Identifier: 08714729796459
• UDI-Public: 08714729796459
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 05/22/2026
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0031673069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 62 KG