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

Model Number	24701
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and fracture occurred.The patient presented with peripheral arterial disease.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal posterior tibial.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, on the first inflation at 6 atmospheres for few seconds, the balloon ruptured.The device was removed and replaced with a 2mm x 40mm x 144cm coyote es balloon catheter, which also ruptured during initial inflation at 6 atmospheres for few seconds.It was also noticed that the devices were also fractured.Both devices were removed intact and the procedure was completed with a 2.0 x 150 coyote balloon catheter.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture and fracture occurred.The patient presented with peripheral arterial disease.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal posterior tibial.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, on the first inflation at 6 atmospheres for few seconds, the balloon ruptured.The device was removed and replaced with a 2mm x 40mm x 144cm coyote es balloon catheter, which also ruptured during initial inflation at 6 atmospheres for few seconds.It was also noticed that the devices were also fractured.Both devices were removed intact and the procedure was completed with a 2.0 x 150 coyote balloon catheter.No patient complications nor injuries were reported.It was further reported that the balloon was ruptured but the catheters were not noted to be fractured.
Event or Problem Description
It was reported that balloon rupture and fracture occurred.The patient presented with peripheral arterial disease.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal posterior tibial.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, on the first inflation at 6 atmospheres for few seconds, the balloon ruptured.The device was removed and replaced with a 2mm x 40mm x 144cm coyote es balloon catheter, which also ruptured during initial inflation at 6 atmospheres for few seconds.It was also noticed that the devices were also fractured.Both devices were removed intact and the procedure was completed with a 2.0 x 150 coyote balloon catheter.No patient complications nor injuries were reported.It was further reported that the balloon was ruptured but the catheters were not noted to be fractured.
Additional Manufacturer Narrative
Updated: b5: describe event or problem.H6: device code.Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 6mm from the tip.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12920634
• Report Number: 2134265-2021-14864
• Device Sequence Number: 4994641
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: 08714729767381
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2022

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: 02/18/2023
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0026829765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 01/11/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/15/2021; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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
• Patient Race: Black Or African American