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	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the markerband was dislodged.The target lesion was located in the kidney.An accustick ii w/o guidewire was selected for use.After withdrawing the device from the patient, it was noted that the silver markerband was found in the upper part of the dilator and not at the end of the introducer.The procedure was completed with this device.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Media inspection of a picture attached, and the reported error is not shown in the photo.Visual inspection of the accustick device was returned with the sheath, 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 damage at distal tip.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.
Event or Problem Description
It was reported that the markerband was dislodged.The target lesion was located in the kidney.An accustick ii w/o guidewire was selected for use.After withdrawing the device from the patient, it was noted that the silver markerband was found in the upper part of the dilator and not at the end of the introducer.The procedure was completed with this device.No complications were reported.

• 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: 18438597
• Report Number: 2124215-2023-74573
• Device Sequence Number: 20741341
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 01/02/2026
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030775916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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 Sex: Unknown