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

Model Number	24704
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The highly stenosed target lesion was located in the moderately tortuous and moderately calcified left arteria tibealis posterior artery.An attempt to advance the 3.0mm x 80mm x 150cm coyote over the 300cm v-14 control wire was made; however the catheter stuck on the wire and the balloon looked like an accordion.The catheter and guidewire were removed together as one unit.Another of the same catheter and guidewire were used to complete the procedure.No patient complications were reported and the patient's status is fine.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: returned product consisted of a coyote balloon catheter with the v14 guidewire in the lumen.The balloon is loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The shaft is kinked in numerous locations.The tip is damaged.The shaft is buckled in numerous locations restricting the movement of the wire.The balloon catheter and wire were soaked in a water bath of warm water for a few days in an attempt to remove the guidewire.The v14 guide wire could not be removed from the coyote balloon catheter due to the extensive shaft buckling.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The highly stenosed target lesion was located in the moderately tortuous and moderately calcified left arteria tibealis posterior artery.An attempt to advance the 3.0mm x 80mm x 150cm coyote over the 300cm v-14 control wire was made; however the catheter stuck on the wire and the balloon looked like an accordion.The catheter and guidewire were removed together as one unit.Another of the same catheter and guidewire were used to complete the procedure.No patient complications were reported and the patient's status is fine.

• 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: 8306623
• Report Number: 2134265-2019-00798
• Device Sequence Number: 13491424
• Product Code: DQY
• UDI-Device Identifier: 08714729796541
• UDI-Public: 08714729796541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 04/29/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0022054786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1