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	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent an arteriogram with angioplasty.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left leg.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.During inflation, before the balloon got to nominal pressure around 4 to 5 atmospheres, there was a balloon leak, and it was confirmed that the balloon ruptured.The device was removed from and replaced for another of the same device to complete the procedure.No were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: coyote es balloon catheter returned.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 41mm from the tip and is approximately 6mm long.No other damages or irregularities found in the remainder of the product analysis.
Additional Manufacturer Narrative
Device evaluated by mfr.: coyote es balloon catheter returned.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 41mm from the tip and is approximately 6mm long.No other damages or irregularities found in the remainder of the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent an arteriogram with angioplasty.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left leg.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.During inflation, before the balloon got to nominal pressure around 4 to 5 atmospheres, there was a balloon leak, and it was confirmed that the balloon ruptured.The device was removed from and replaced for another of the same device to complete the procedure.No were no patient complications.It was further reported that the balloon ruptured when inflating for the first time at 6 atmospheres.

• 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: 19140842
• Report Number: 2124215-2024-23790
• Device Sequence Number: 20702433
• Product Code: LIT
• UDI-Device Identifier: 08714729767411
• UDI-Public: 08714729767411
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 08/27/2025
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0032306520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Race: White