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

Model Number 24691

Device Problem Material Rupture (1546)

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 mildly tortuous and mildly calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 14 atmospheres, the balloon ruptured.The device was removed from the patient's body without any problem and the procedure was completed with another of the same 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 outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed a pinhole 14mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a rupture in the balloon.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 14 amospheres, the balloon ruptured.The device was removed from the patient's body without any problem and the procedure was completed with another of same device.No patient complications were reported and the patient was in good condition.

• 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: 11092201
• MDR Text Key: 224397653
• Report Number: 2134265-2020-18561
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767169
• UDI-Public: 08714729767169
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0025295858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1