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

Model Number	35615
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radio opaque tip fell off.An accustick was selected for use.During the procedure, when removing the device, it was noted that the radio opaque tip fell off and was retrieved.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5: describe event or problem: updated.
Event or Problem Description
It was reported that the radio opaque tip fell off.An accustick was selected for use.During the procedure, when removing the device, it was noted that the radio opaque tip fell off and was retrieved.There were no patient complications as a result of this event.It was further reporter that the radio opaque tip when retrieved was barely on when removed and then fell off when it was out of the body.
Event or Problem Description
It was reported that the radio opaque tip fell off.An accustick was selected for use.During the procedure, when removing the device, it was noted that the radio opaque tip fell off and was retrieved.There were no patient complications as a result of this event.It was further reporter that the radio opaque tip when retrieved was barely on when removed and then fell off when it was out of the body.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the accustick device was returned to our post market quality assurance laboratory.The working length was returned, and it was possible to observed that it was bent.The device was inspected under the microscope; it could be observed that the ro marker was not in the correct position.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24676234
• Report Number: 2124215-2026-16112
• Device Sequence Number: 10149321
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: (01)08714729157625(17)281208(10)38143633
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 05/12/2026

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 Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0038143633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/17/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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