MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401051
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used during a pc tj liver biopsy procedure in the liver performed on (b)(6) 2023.During the procedure, it was found that the coating wire was stripped, and then they took of the catheter.The procedure was successfully completed with another amplatz super stiff device.There were no patient complications reported as a result of this event.Investigation results revealed that the core wire was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of core wire detached or separated.Block h10: the returned amplatz super stiff was analyzed, and upon magnification it was observed that the coil wire was unraveled due the core wire was found detached separated approximately 3.0 cm from distal tip to the transition point.Additionally, the core wire was kinked in the distal section.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event of ptfe peeled was not confirmed.However, it was observed that the coil wire was unraveled due to the core wire being found to be detached approximately 3.0 cm from the distal tip to the transition point, and the core wire was also found to be kinked in the distal section.Therefore, the probable cause of manufacturing deficiency will be assigned to this complaint since the problem found was traced to the design specification.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18314320
• Report Number: 3005099803-2023-06612
• Device Sequence Number: 12442079
• Product Code: EZB
• UDI-Device Identifier: 08714729191155
• UDI-Public: 08714729191155
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: 05/08/2025
• Device Model Number: M0066401051
• Device Catalogue Number: 640-105
• Device Lot Number: 0029366994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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