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

Model Number	24701
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The 90% stenosed target lesion was located in the non-tortuous and severely calcified tibial peritoneal trunk.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 3-4 atmospheres, the balloon ruptured and a part of balloon could not be removed.The unretrieved part was attempted to be snared and another balloon was placed to drag the piece but failed to be removed.A stent was placed and pinned the balloon piece against the vessel wall and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mf: returned product consisted of a coyote es balloon catheter with a 0.014" guidewire stuck inside the guidewire lumen.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple buckling along the guidewire lumen.The balloon is separated 147.5cm from the hub.The guidewire lumen is separated into two pieces on the guidewire.One piece is 168.8cm and the other section is 67.7cm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a rupture in the balloon and the difficulty to remove.
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The 90% stenosed taget lesion was located in the non-tortuous and severely calcified tibial peritoneal trunk.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 3-4 atmospheres, the balloon ruptured and a part of balloon could not be removed.The unretrieved part was attempted to be snared and another balloon was placed to drag the piece but failed to be removed.A stent was placed and pinned the balloon piece against the vessel wall and the procedure was completed.No patient complications were reported.

• 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: 11852704
• Report Number: 2134265-2021-06402
• Device Sequence Number: 3724266
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: 08714729767381
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0026814807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention