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

Model Number 35615

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

Additional information reported the staff was not able to tell which of the provided lot numbers was the faulty one or which one was used successfully.By this, the device that had to be snared may have come from one of the following batch/lot numbers (30173514 and 30751657).

Event Description

It was reported that a markerband detachment occurred and additional intervention was required.The target lesion was located in the kidney.An accustick ii was selected for use.During the procedure, while inserting the introducer sheath, the radiopaque marker band moved away from the tip preventing the physician from seeing where the tip of the sheath was under fluoroscopy.During an attempt to advance the sheath, the kidney was perforated with the tip of the introducer sheath.Another accustick package was opened, and the same thing happened with the next 3 sheaths.The marker band had moved; the patient already had contrast in the kidney, so visibility was an issue to begin with.One of the marker bands from a different kit actually came completely off and had to be snared out of the kidney on its own.The procedure was successfully completed with another of the same device.The patient was expected to fully recover.

• Brand Name: ACCUSTICK II
• Type of Device: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16708346
• MDR Text Key: 312964601
• Report Number: 2124215-2023-14018
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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: 0030751657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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