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

Model Number	35615
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that markerband malposition occurred.Two accustick ii kits were selected for use in the kidney for nephrostomy drain placement.During the procedure, the physician had difficulty advancing the sheaths on the accusticks and it was noted that the ro markers would slide up the sheath impairing his vision.When the device was advanced through the skin, the marker stayed at the skin as the device advanced into the patient.It happened with two devices in a row.The skin incision was appropriate.The physician commented that he had never seen the marker slide down.The sheaths were also noted to be kinked at the distal tip of the device.The devices were pulled out intact from the patient's body and the procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The accustick device was returned, and it was observed that the ro marker was out of its location in the device middle section since it moves freely.Additionally, the accustick device was bent at ro marker actual location and had the distal tip was broken.No more damages were observed.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 is 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 9.5cm from the distal tip and does not meet specification.The od (outer diameter) of the ro marker could not be measured due the accustick device was bent at ro marker actual location.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that markerband malposition occurred.Two accustick ii kits were selected for use in the kidney for nephrostomy drain placement.During the procedure, the physician had difficulty advancing the sheaths on the accusticks and it was noted that the ro markers would slide up the sheath impairing his vision.When the device was advanced through the skin, the marker stayed at the skin as the device advanced into the patient.It happened with two devices in a row.The skin incision was appropriate.The physician commented that he had never seen the marker slide down.The sheaths were also noted to be kinked at the distal tip of the device.The devices were pulled out intact from the patient's body and the procedure was completed with this 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: 16484908
• Report Number: 2124215-2023-09514
• Device Sequence Number: 14867864
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: 08714729201137
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 03/28/2023

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: 01/02/2026
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030776020
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/28/2023
• 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