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

Model Number 24691

Device Problem Material Rupture (1546)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during the initial inflation at 10 atmospheres for 10 seconds, the balloon ruptured at the proximal side.The device was removed without any problem and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was good.

• Brand Name: COYOTE ES
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15029228
• MDR Text Key: 296048130
• Report Number: 2124215-2022-25884
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767169
• UDI-Public: 08714729767169
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0027619882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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