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

Model Number	24701
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter and guidewire entrapment, pain and aborted procedure occurred.The 100% stenosed target lesion was located in the mildly calcified distal superficial femoral artery.A 3.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.The balloon was deployed; however, during withdrawal, the physician could not remove the balloon over the choice guidewire.The balloon and the wire were entirely removed as one unit.The physician decided to abort the procedure because the patient was having so much back pain.No patient complications were reported.The patient will return at a later date to be treated with atherectomy.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter with a 0.014 guidewire stuck inside.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter and guidewire entrapment, pain and aborted procedure occurred.The 100% stenosed target lesion was located in the mildly calcified distal superficial femoral artery.A 3.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.The balloon was deployed; however, during withdrawal, the physician could not remove the balloon over the choice guidewire.The balloon and the wire were entirely removed as one unit.The physician decided to abort the procedure because the patient was having so much back pain.No patient complications were reported.The patient will return at a later date to be treated with atherectomy.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11797607
• Report Number: 2134265-2021-05878
• Device Sequence Number: 11726143
• Product Code: LIT
• UDI-Device Identifier: 08714729767442
• UDI-Public: 08714729767442
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 03/09/2022
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0025325247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR