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 04/20/2023

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during the first inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16818297
• MDR Text Key: 314042540
• Report Number: 2124215-2023-19902
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0031179628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: GUIDE CATHETER: PARENT.; GUIDEWIRE: JUPITER.; MICRO CATHETER: ARMET.