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

Model Number	35615
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that markerband malposition occurred.An accustick ii was selected for use in the percutaneous transhepatic biliary drainage (ptbd).During the procedure, it was noted that the marker position was behind the original position.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was observed that the ro marker was found in the device proximal section since it moves freely.Additionally, the distal tip was damaged.The device was inspected under the microscope, and it was observed to be damaged at the distal tip, this damage is located next to the ro marker position.There is evidence of the correct ro marker colocation at the device distal end section.The ro marker outer diameter was measured in order to confirm the correct ro marker position and was found to be within specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that markerband malposition occurred.An accustick ii was selected for use in the percutaneous transhepatic biliary drainage (ptbd).During the procedure, it was noted that the marker position was behind the original position.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ACCUSTICK II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16279203
• Report Number: 2124215-2023-03996
• Device Sequence Number: 6522147
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 11/07/2025
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030502970
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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 Sex: Unknown