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

Model Number	24691
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter became entrapped on the guidewire.A v-14 control wire and a 3.5mm x 40mm x 146cm coyote es balloon catheter were selected for use for a celiac stenting procedure.However, during the procedure, the devices became stuck.The wire was sloppy wet and the balloon was flushed with heparin saline.It was very difficult to pull off the wire.There were no patient complications nor injuries reported and the patient was fine.
Event or Problem Description
It was reported that the catheter became entrapped on the guidewire.A v-14 control wire and a 3.5mm x 40mm x 146cm coyote es balloon catheter were selected for use for a celiac stenting procedure.However, during the procedure, the devices became stuck.The wire was sloppy wet and the balloon was flushed with heparin saline.It was very difficult to pull off the wire.There were no patient complications nor injuries reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of a coyote es balloon catheter.The shafts, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded bunched up.Inspection of the device revealed that the outer shaft and wire lumen were detached 5mm distal of the exit notch.The outer shaft was stretched from the exit notch to the balloon.The wire lumen was buckled from the separation to the tip.The distal tip was damaged.The confirmed damage to the device is consistent to be damage caused by the guidewire being stuck on the device during the procedure.Product analysis confirmed the reported event, as the damage to the device is consistent to be damage caused by the guidewire being stuck on the device during the procedure.

• 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: 9396798
• Report Number: 2134265-2019-14534
• Device Sequence Number: 2660091
• Product Code: LIT
• UDI-Device Identifier: 08714729767282
• UDI-Public: 08714729767282
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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 Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0023699062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V-14 CONTROL WIRE; GUIDEWIRE: V-14 CONTROL WIRE