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

Model Number	24704
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient underwent a peripheral angiogram on the patient's right leg using a destination crossover sheath in the left groin via the superficial femoral artery (sfa) which revealed a chronic total occlusion in the p2-p3 segment of popliteal artery.After crossing the lesion with a non-boston scientific (bsc) guidewire, laser was used to prepare the lesion and blood flow was confirmed.A 3.5mm x 80mm x 150cm coyote balloon catheter was advanced over the wire; however, once the coyote balloon was just proximal to the target area, the balloon seized and would not move no matter how hard it was pushed or pulled.Fluid was injected into the area in attempt to get the balloon to move over the wire, but the balloon was stuck.The balloon and the wire were pulled together and removed out of the body.A new non-bsc guidewire was placed, and the lesion was dilated with a non-bsc balloon.The procedure was successfully completed, and the patient was recovering as normal.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 damage to the guidewire lumen 79cm from the tip.No other damage or irregularities found.Product analysis found damage to the device that would have contributed to the reported event.
Event or Problem Description
It was reported that device entrapment occurred.The patient underwent a peripheral angiogram on the patient's right leg using a destination crossover sheath in the left groin via the superficial femoral artery (sfa) which revealed a chronic total occlusion in the p2-p3 segment of popliteal artery.After crossing the lesion with a non-boston scientific (bsc) guidewire, laser was used to prepare the lesion and blood flow was confirmed.A 3.5mm x 80mm x 150cm coyote balloon catheter was advanced over the wire; however, once the coyote balloon was just proximal to the target area, the balloon seized and would not move no matter how hard it was pushed or pulled.Fluid was injected into the area in attempt to get the balloon to move over the wire, but the balloon was stuck.The balloon and the wire were pulled together and removed out of the body.A new non-bsc guidewire was placed, and the lesion was dilated with a non-bsc balloon.The procedure was successfully completed, and the patient was recovering as normal.

• 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: 19139917
• Report Number: 2124215-2024-23392
• Device Sequence Number: 18251194
• Product Code: DQY
• UDI-Device Identifier: 08714729796596
• UDI-Public: 08714729796596
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: 08/07/2026
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0032169565
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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: GUIDEWIRES: SPIDER WIRE FX; GUIDEWIRES: SPIDER WIRE FX
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 80 KG