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

Model Number 35615

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/22/2023

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 323349520
• Report Number: 2124215-2023-49177
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention