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

Model Number	24705
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 85 percent stenosed target lesion was located in a mildly calcified and mildly tortuous lesion below the knee.A 2.5mm x 120mm x 150cm, otw coyote balloon catheter was advanced over the guidewire.However, after crossing about 20cm on the guidewire, the catheter was stuck and the physician was unable to advance or retrieve the catheter.It was observed that the catheter tip was kinked.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
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 multiple kinks along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the reported event.
Event or Problem Description
It was reported that catheter entrapment occurred.The 85 percent stenosed target lesion was located in a mildly calcified and mildly tortuous lesion below the knee.A 2.5mm x 120mm x 150cm, otw coyote balloon catheter was advanced over the guidewire.However, after crossing about 20cm on the guidewire, the catheter was stuck and the physician was unable to advance or retrieve the catheter.It was observed that the catheter tip was kinked.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11464596
• Report Number: 2134265-2021-03204
• Device Sequence Number: 3946709
• Product Code: DQY
• UDI-Device Identifier: 08714729796527
• UDI-Public: 08714729796527
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 06/24/2023
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0025634757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR