MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number 35615

Device Problem Defective Device (2588)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section.No more damages were observed.

Event Description

It was reported that markerband disposition occurred.A.038 j accustick ii was selected for use in the percutaneous transhepatic.During the procedure, it was noted that the ro marker was moved out of location while accessing the lesion percutaneously.The device was removed, and the procedure was completed with a new accustick.No patient complications were reported.

• Brand Name: ACCUSTICK II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17166651
• MDR Text Key: 317816637
• Report Number: 2124215-2023-28658
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030905353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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