MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

Device Problem Material Deformation (2976)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of an agent (dcb) balloon catheter.The device was microscopically and visually examined.The hypotube was separated 65.4cm from the strain relief.There were numerous kinks to both the hypotube and shaft of the device.The separated ends were oval shaped indicating that the device was kinked prior to separation.The balloon was tightly folded, and there was contrast and blood in the folds.The coating to the balloon was still intact.

Event Description

Reportable based on device analysis completed on 16nov2022.The 3.00 mm x 30.00 mm agent dcb (drug coated balloon) was selected for use.It was noted that there was a shaft kink.No patient complications were reported.However, device analysis revealed hypotube separation.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15837503
• MDR Text Key: 305592694
• Report Number: 2124215-2022-48091
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 00580H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1