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	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The accustick device was returned with the dilator and the canula.It was observed that the radiopaque (ro) marker was out of its location in the device distal section since it moves freely.Additionally, the accustick device was bent, the distal tip was broken and the canula was observed to be bent.The device was inspected under microscope, and it was observed that the broken distal tip is located next to the ro marker position.Evidence of the correct ro marker colocation was observed at device distal end section.The device was measured in order to confirm the ro marker position; and the ro marker was located approximately at 5.1cm from the distal tip.
Event or Problem Description
It was reported that a markerband malposition occurred.The target lesion was located in the kidney.An accustick ii was selected for use.During the procedure, while inserting the introducer sheath, the radiopaque marker band moved away from the tip preventing the physician from seeing where the tip of the sheath was under fluoroscopy.During an attempt to advance the sheath, the kidney was perforated with the tip of the introducer sheath.Another accustick package was opened, and the same thing happened with the next 3 sheaths.The marker band had moved; the patient already had contrast in the kidney, so visibility was an issue to begin with.One of the marker bands from a different kit actually came completely off and had to be snared out of the kidney on its own.The procedure was successfully completed with another of the same device.The patient was expected to fully recover.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16708230
• Report Number: 2124215-2023-13364
• Device Sequence Number: 19729148
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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: 09/18/2025
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030173514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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