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	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and leak occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.A 2mm x 40mm x 144cm coyote es balloon catheter was advanced for dilation.During the second inflation, at 8 atmospheres there was a leak noted, and in the same atmospheric pressure for about 10 seconds, the balloon ruptured.In addition, it was confirmed that the device was not used to post-dilate a previously placed stent.The balloon was successfully removed from the patient with no fragments left inside and was replaced for a different device to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 43mm from the tip.No other damages or irregularities were presented in the remainder of the examination.
Event or Problem Description
It was reported that balloon rupture and leak occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.A 2mm x 40mm x 144cm coyote es balloon catheter was advanced for dilation.During the second inflation, at 8 atmospheres there was a leak noted, and in the same atmospheric pressure for about 10 seconds, the balloon ruptured.In addition, it was confirmed that the device was not used to post-dilate a previously placed stent.The balloon was successfully removed from the patient with no fragments left inside and was replaced for a different device to complete the procedure.There were no patient complications reported.It was further reported that physical evidence to the balloon was noted where the balloon ruptured upon inflation.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19274343
• Report Number: 2124215-2024-27741
• Device Sequence Number: 20690452
• Product Code: LIT
• UDI-Device Identifier: 08714729767350
• UDI-Public: 08714729767350
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 03/28/2025
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0031326803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female