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	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the markerband moved from the original position.An accustick ii was selected for use.During preparation, it was noted that the device ro marker was not in the original position.The procedure was completed with a different device.There were no patient complications.
Event or Problem Description
It was reported that the markerband moved from the original position.An accustick ii was selected for use.During preparation, it was noted that the device ro marker was not in the original position.The procedure was completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
Media analysis: the complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section and the accustick device was observed bent.No more damages were observed.Updated fields: evaluation method codes, evaluation result codes, evaluation result codes.
Additional Manufacturer Narrative
Media analysis: the complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section and the accustick device was observed bent.No more damages were observed.Updated fields: evaluation method codes, evaluation result codes, evaluation result codes 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 ro marker was out of its location in the device distal section since it moves freely.Additionally, the accustick device was bent and had the distal tip was broken.The canula was observed bent.The pouch was returned, and it was observed that the pouch information matches with the complaint information.The device was inspected under microscope, and it was observed that the distal tip was broken, 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.The device was measured in order to confirm the ro marker position; and the ro marker was located approximately at 7,1 cm from the distal tip.
Event or Problem Description
It was reported that the markerband moved from the original position.An accustick ii was selected for use.During preparation, it was noted that the device ro marker was not in the original position.The procedure was completed with a different device.There were no patient complications.The complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section and the accustick device was observed bent.No more damages were observed.

• 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: 17142620
• Report Number: 2124215-2023-28358
• Device Sequence Number: 11239681
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: 08714729201137
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 08/10/2023

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: 10/31/2025
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030457679
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 07/20/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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 Age: 76 YR
• Patient Sex: Female