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

Model Number 24691

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed, target lesion was located in a severely tortuous and severely calcified superior femoral artery.A 4mm x 20mm x 144cm coyote es balloon was advanced for dilation.However, during inflation at 10 atmospheres with a 3 seconds of inflation duration, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

(b)(6).Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.There was blood in the inflation lumen.Microscopic examination revealed a tear 19mm in length on the distal end of the balloon.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.The damage to the balloon is consistent with interaction with the lesion.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed, target lesion was located in a severely tortuous and severely calcified superior femoral artery.A 4mm x 20mm x 144cm coyote es balloon was advanced for dilation.However, during inflation at 10 atmospheres with a 3 seconds of inflation duration, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.

• 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: 9455673
• MDR Text Key: 176377584
• Report Number: 2134265-2019-15627
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0022652290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1