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

Model Number	H74939186302210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified anterior tibial artery (ata).After the dilatation was performed in the left popliteal artery with 3.0mm x 220mm x 150cm coyote balloon catheter, the ata was attempted to be dilated.After crossing the lesion, the balloon was initially inflated at 6 atmospheres for 10 seconds.However, it ruptured before reaching the nominal pressure.The device was removed from the sheath without any problems, and the procedure was completed using a different balloon.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear 8.6cm from the tip and is approximately 6.5cm 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.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified anterior tibial artery (ata).After the dilatation was performed in the left popliteal artery with 3.0mm x 220mm x 150cm coyote balloon catheter, the ata was attempted to be dilated.After crossing the lesion, the balloon was initially inflated at 6 atmospheres for 10 seconds.However, it ruptured before reaching the nominal pressure.The device was removed from the sheath without any problems, and the procedure was completed using a different balloon.No complications were reported.

• 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: 20843823
• Report Number: 2124215-2024-76173
• Device Sequence Number: 3838569
• Product Code: DQY
• UDI-Device Identifier: 08714729797265
• UDI-Public: 08714729797265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/26/2024

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 Model Number: H74939186302210
• Device Catalogue Number: H74939186302210
• Device Lot Number: 0032602948
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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 Sex: Male