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

Model Number	24699
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 5082 non-bsc introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 4.0mm x 220mm x 150cm coyote balloon catheter.However, during the first inflation at 8 atmospheres for 20 seconds, the balloon ruptured at the middle portion.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications nor injuries reported and the patient was in good condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 5082 non-bsc introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 4.0mm x 220mm x 150cm coyote balloon catheter.However, during the first inflation at 8 atmospheres for 20 seconds, the balloon ruptured at the middle portion.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications nor injuries reported and the patient was in good condition.
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.Device evaluated by mfr.: 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 pinhole 57mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16806753
• Report Number: 2124215-2023-19694
• Device Sequence Number: 1929623
• Product Code: DQY
• UDI-Device Identifier: 08714729796404
• UDI-Public: 08714729796404
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 04/17/2025
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0029241625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: MACH1/6FR; GUIDE CATHETER: MACH1/6FR; GUIDEWIRE: JUPITER; GUIDEWIRE: JUPITER; INFLATION DEVICE: BASIC COMPAQ; INFLATION DEVICE: BASIC COMPAQ; INTRODUCER SHEATH: PARENT 5082; INTRODUCER SHEATH: PARENT 5082; MICRO CATHETER: TORQ PORTER; MICRO CATHETER: TORQ PORTER
• Patient Sex: Male