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

Model Number 35615

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that the ro marker was pushed.The target lesion was located in the biliary.A accustick ii w/o guidewire was selected for use.During the procedure, the dilator was inserted into the patient, but could not see the angiomark.The device was removed from the patient and found that the angiomark was pushed.The procedure was completed with another of the same device.No complications were reported and the patient was fine.

Event Description

It was reported that the ro marker was pushed.The target lesion was located in the biliary.A accustick ii w/o guidiwire was selected for use.During the procedure, the dilator was inserted into the patient, but could not see the angiomark.The device was removed from the patient and found that the angiomark was pushed.The procedure was completed with another of the same device.No complications were reported, and the patient was fine.

Manufacturer Narrative

Device evaluated by mfr.: the accustick device was returned with the dilator and the canula stuck inside the device.It was observed that the ro marker was out of its location due it was separated from the accustick device.Additionally, the accustick device was kinked and had the distal tip was damage.No more damages were observed.The device was inspected under microscope, and it was observed that the distal tip was damage, this damage is located next to the ro marker position.It's important to mention that evidence of correct ro marker colocation was observed at device distal end section.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17745337
• MDR Text Key: 323399133
• Report Number: 2124215-2023-49202
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: 0030874095
• 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: 01/18/2023
• 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 Age: 49 YR
• Patient Sex: Male