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

Model Number	24691
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the calcified and non-tortuous carotid artery.A 3mm x 30mm x 145cm coyote es balloon catheter was advanced for dilation.However, during second inflation under the pressure of safety for few seconds, the balloon burst.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a coyote es balloon catheter.The balloon was loosely folded and bloody.Analysis of the tip, balloon, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a burst in the balloon material that was 15mm in length.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the calcified and non-tortuous carotid artery.A 3mm x 30mm x 145cm coyote es balloon catheter was advanced for dilation.However, during second inflation under the pressure of safety for few seconds, the balloon burst.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.

• 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: 11007337
• Report Number: 2134265-2020-17714
• Device Sequence Number: 3813309
• Product Code: LIT
• UDI-Device Identifier: 08714729767244
• UDI-Public: 08714729767244
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 06/09/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0025576438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 74