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

Model Number	24701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and heavily calcified left posterior tibial artery with no significant bend.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another balloon at the same size.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
B3.Date of event: corrected from (b)(6) 2021 to (b)(6) 2021.B5.Describe event or problem: corrected and updated.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and heavily calcified left posterior tibial artery with no significant bend.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another balloon at the same size.No patient complications nor injuries were reported.It was further reported that percentage of stenosis was a 99% and not 90% as previously reported.There were no significant bends noted in the lesion.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and heavily calcified left posterior tibial artery with no significant bend.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another balloon at the same size.No patient complications nor injuries were reported.It was further reported that percentage of stenosis was a 99% and not 90% as previously reported.There were no significant bends noted in the lesion.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 15mm from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11369576
• Report Number: 2134265-2021-02259
• Device Sequence Number: 17090418
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: 08714729767381
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 04/02/2021

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: 10/13/2022
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0026175630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/26/2021; 03/26/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/17/2021; 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR