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

Model Number	35615
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2023-49202
• Device Sequence Number: 5281841
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male