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

Model Number	24698
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 150mm x 150cm, coyote balloon catheter was advanced for dilation.During the procedure, device was inflated to expand the artery route, but it ruptured upon second to third inflation during insertion and removal attempts.The tip of the balloon was separated in the body around 10cm.An eluvia self-expanding stent was used to entrap the detached component in the vessel.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.

• 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: 19772629
• Report Number: 2124215-2024-43956
• Device Sequence Number: 18235504
• Product Code: DQY
• UDI-Device Identifier: 08714729797098
• UDI-Public: 08714729797098
• 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
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0032759342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - JUPITER FC3 S6 GLADIUS; INTRODUCER SHEATH - PARENT 6F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown