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

Model Number 24699

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified right anterior tibial artery.A 2.0mm x 220mm x 150cm, mr coyote balloon catheter was advanced but the device was unable to cross the lesion.The balloon was inflated.However, during inflation at 6 atmospheres for 10 seconds, the balloon ruptured and a balloon pinole was noted.The device was removed without problem.The procedure was completed with another 2mmx15cm coyote balloon catheter.There were no patient complications nor injuries reported.

• Brand Name: COYOTE
• Type of Device: 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: 12124971
• MDR Text Key: 260219818
• Report Number: 2134265-2021-08586
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729796817
• UDI-Public: 08714729796817
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0026977213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1