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

Model Number	24698
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon got stuck in the guidewire lumen.An endovascular therapy was performed for the chronic total occlusion (cto) from the common iliac artery to the external iliac artery.A 4.0mm x 150mm x 150cm coyote balloon catheter was used selected for treatment.After passing the guidewire, the device was inflated before it was removed.During the procedure, when inserting into the sheath after imaging, the device got stuck in the guidewire lumen and could not be re-inserted into the sheath.A different device was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.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 a kink to the guidewire lumen 15.5cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon got stuck in the guidewire lumen.An endovascular therapy was performed for the chronic total occlusion (cto) from the common iliac artery to the external iliac artery.A 4.0mm x 150mm x 150cm coyote balloon catheter was used selected for treatment.After passing the guidewire, the device was inflated before it was removed.During the procedure, when inserting into the sheath after imaging, the device got stuck in the guidewire lumen and could not be re-inserted into the sheath.A different device was used to complete the procedure.There were no patient complications reported.It was further reported that the lesion was 100% stenosed, moderately tortuous, and moderately calcified.When the physician attempted to reinsert the balloon, it got stuck in the guidewire lumen so it couldn't insert anymore.There were no damages or defects noted on the device.

• 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: 20300710
• Report Number: 2124215-2024-59293
• Device Sequence Number: 7588314
• 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,Followup
• Report Date (Section B): 10/14/2024

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: 06/12/2025
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0029579670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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 Sex: Unknown