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

Model Number	24691
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.A 3.5mm x 30mm x 145cm coyote es balloon catheter was selected for use.However, the balloon fell off the shaft outside the patient.There was no harm to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter in two pieces.The distal part of the shaft was returned on an unidentified.014" guidewire.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft was completely separated 118.4cm from the hub.The fractured/separated end of the shaft was stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube and shaft kinks.The distal inner shaft is buckled in numerous locations, the wire could not be removed from the device due to the buckling.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon detachment occurred.A 3.5mm x 30mm x 145cm coyote es balloon catheter was selected for use.However, the balloon fell off the shaft outside the patient.There was no harm to the patient.

• 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: 8560617
• Report Number: 2134265-2019-04490
• Device Sequence Number: 1537999
• Product Code: LIT
• UDI-Device Identifier: 08714729767275
• UDI-Public: 08714729767275
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 03/05/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0023442556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1