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

Model Number	35615
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire detached inside the patient.On (b)(6) 2024, a patient underwent a right nephrostomy tube placement procedure during which a guidewire broke, leaving a 30.2 cm portion retained in the patient's right kidney pelvis.The radiologist reported that no undue stress, such as tugging, pushing, or pulling, was applied to the guidewire prior to its breakage, and the broken segment could not be retrieved during the initial procedure.Subsequent to the incident, the patient required two additional procedures to address the retained guidewire.On (b)(6) 2024, a right ureteroscopic laser lithotripsy was performed with the aim of removing the foreign body.During this procedure, a 1.6 cm piece of the guidewire was successfully extracted from the right kidney pelvis; however, the remaining portion could not be removed.A second procedure was performed on (b)(6) 2024, involving a right partial ureterectomy and ureteropyelostomy with double-j stent placement.This procedure successfully removed the remaining 28.6 cm portion of the guidewire.The patient condition remained stable, and there were no adverse effects from the retained guidewire.The patient was discharged on july 19, 2024, and a follow-up with the urologist indicated a successful recovery with no complications related to the broken guidewire.

• 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: 20015520
• Report Number: 2124215-2024-49966
• Device Sequence Number: 12911747
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: 08714729201137
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 08/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0033872098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 04/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown