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

Model Number 24691

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 4mm x 20mm x 144cm coyote es balloon catheter was advanced for dilatation.However, during the second inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient was in good condition.

Manufacturer Narrative

Device evaluated by mfr.: 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 25mm in length, and numerous kinks were observed in the hypotube shaft.Inspection of the rest of the device found no other damage or defects.The reported balloon rupture was confirmed.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 4mm x 20mm x 144cm coyote es balloon catheter was advanced for dilatation.However, during the second inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient was in good condition.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 25mm in length, and numerous kinks were observed in the hypotube shaft.Inspection of the rest of the device found no other damage or defects.The reported balloon rupture was confirmed.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11094332
• MDR Text Key: 224398053
• Report Number: 2134265-2020-18579
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767299
• UDI-Public: 08714729767299
• Combination Product (y/n): N
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0026117653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1