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

Model Number	35615
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the radiopaque marker was left in the patient.The target lesion was located in the left kidney.A new nephostromy tube is being placed and a.038 accustick ii introducer system was selected for use.A.018 wire and amplatz guidewire was placed through the 0.38 lumen.During removal of the dilator from the patient, the radiopaque marker was retained in the skin.The radiopaque marker was attempted to retrieve percutaneously with hemostats, a dilator and a non-boston scientific balloon catheter, but it was unsuccessful.Eventually, a nephrostomy tube was then placed, and the radiopaque marker was left in the renal pelvis.The patient is doing fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the accustick device was returned with the dilator and the canula stuck inside the device.It was observed that the ro marker was out of its location due it was separated from the accustick device.Additionally, the accustick device was kinked and had the distal tip was damage.No other damages were observed.The device was inspected under microscope, and it was observed that the distal tip was damage, 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.
Event or Problem Description
It was reported that the radiopaque marker was left in the patient.The target lesion was located in the left kidney.A new nephostromy tube is being placed and a.038 accustick ii introducer system was selected for use.A.018 wire and amplatz guidewire was placed through the 0.38 lumen.During removal of the dilator from the patient, the radiopaque marker was retained in the skin.The radiopaque marker was attempted to retrieve percutaneously with hemostats, a dilator and a non-boston scientific balloon catheter, but it was unsuccessful.Eventually, a nephrostomy tube was then placed, and the radiopaque marker was left in the renal pelvis.The patient is doing fine.

• 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: 17741274
• Report Number: 2124215-2023-49177
• Device Sequence Number: 20491659
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 10/17/2023

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 Expiration Date: 05/07/2026
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0031570658
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown