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

Model Number	24699
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon perforation occurred.A 4.0mm x 220mm x 150cm coyote balloon catheter was selected to treat the superficial femoral artery.During the procedure, a perforation was noted on the balloon when it was inflated.The device was replaced for another of the same model to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that balloon perforation occurred.A 4.0mm x 220mm x 150cm coyote balloon catheter was selected to treat the superficial femoral artery.During the procedure, a perforation was noted on the balloon when it was inflated.The device was replaced for another of the same model to complete the procedure.There were no patient complications reported.It was further reported that the balloon inflated only once before it perforated at 10 atmospheres.There was no visible pinhole, tear, or visible damage noted on the balloon.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis and underwent a visual and microscopical examination on the outer shaft, inner shaft, balloon, and tip.The results revealed a longitudinal tear 17.5cm from the tip and is approximately 3cm long.There were no other damages found.
Event or Problem Description
It was reported that balloon perforation occurred.A 4.0mm x 220mm x 150cm coyote balloon catheter was selected to treat the superficial femoral artery.During the procedure, a perforation was noted on the balloon when it was inflated.The device was replaced for another of the same model to complete the procedure.There were no patient complications reported.It was further reported that the balloon inflated only once before it perforated at 10 atmospheres.There was no visible pinhole, tear, or visible damage noted on the balloon.

• 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: 19588251
• Report Number: 2124215-2024-38165
• Device Sequence Number: 15273703
• Product Code: DQY
• UDI-Device Identifier: 08714729796404
• UDI-Public: 08714729796404
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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,Followup
• Report Date (Section B): 09/23/2024

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: 07/31/2025
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0029869096
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 08/29/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/30/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG