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

Model Number 24691

Device Problems Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919)

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

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported that device separation occurred.This 3mm x 40mm x 146cm coyote es balloon catheter was selected for use in an endovascular therapy procedure.The 99% stenosed, moderately calcified, and severely tortuous lesion was located below the knee.This coyote balloon was inflated in the lesion, and when attempting to dilate and then withdraw the balloon, resistance was felt while removing it.When it was removed, the balloon end was separated.It was noted that an eluvia stent was implanted approximately two to three years ago in the popliteal vessel and had fractured due to the joint site.When this coyote balloon was used, it was thought to have become stuck on the fractured stent.Another balloon was inflated distal to the fragment, and the fragment was able to be removed withdrawing it to the guide catheter.The procedure was completed with a non-boston scientific device and plain old balloon angioplasty.There was no patient injury.

Event Description

It was reported that device separation occurred.This 3mm x 40mm x 146cm coyote es balloon catheter was selected for use in an endovascular therapy procedure.The 99% stenosed, moderately calcified, and severely tortuous lesion was located below the knee.This coyote balloon was inflated in the lesion, and when attempting to dilate and then withdraw the balloon, resistance was felt while removing it.When it was removed, the balloon end was separated.It was noted that an eluvia stent was implanted approximately two to three years ago in the popliteal vessel and had fractured due to the joint site.When this coyote balloon was used, it was thought to have become stuck on the fractured stent.Another balloon was inflated distal to the fragment, and the fragment was able to be removed withdrawing it to the guide catheter.The procedure was completed with a non-boston scientific device and plain old balloon angioplasty.There was no patient injury.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this coyote es balloon catheter was visually and microscopically examined.Visual examination revealed a kink to the inflation lumen 25.7cm from the tip.The inflation lumen was separated 36.2cm from the tip.There was a longitudinal tear in the balloon 3ccm from the tip and was approximately 21mm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the inflation lumen was separated.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17756976
• MDR Text Key: 323519950
• Report Number: 2124215-2023-49368
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767251
• UDI-Public: 08714729767251
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0031179638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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
• Patient Outcome(s): Required Intervention