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

Model Number	M0066401040
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material.
Event or Problem Description
It was reported that during preparation of a retrograde intrarenal surgery, when the guidewire was pushed into the scope, the coil of the guidewire has unwound after applying force because of the feeling of foreign matter.It was further reported that there was an unidentifiable foreign body that was not present on the guide wire.The procedure was completed with another of the same device without patient complications.The patient outcome following the procedure was reported to be good.
Additional Manufacturer Narrative
Additional information received clarified that there was no foreign material present at any point.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was initially reported that during preparation of a retrograde intrarenal surgery, when the guidewire was pushed into the scope, the coil of the guidewire has unwound after applying force because of the feeling of foreign matter.Additional information received clarified that there was no foreign material present at any point.Reportedly, the soft tip of guidewire was slightly bent, and the coil of the guidewire was noted unwound upon removal from scope.The procedure was completed with another of the same device without patient complications.The patient outcome following the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of core wire break.Block h11: the returned amplatz wire was analyzed, and it was observed that the core wire was found separated from the bald weld.Also, the guidewire was stretched and bent at distal section.With all the available information, boston scientific concludes that the reported event of device unraveled material and tip kinked can be confirmed, however the device interaction with another device cannot be confirmed.Based on the analysis, it is probable that excessive handling of the device during the use in procedure could have affected the performance and integrity of the device.Based on the analysis results, and investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was initially reported that during preparation of a retrograde intrarenal surgery, when the guidewire was pushed into the scope, the coil of the guidewire has unwound after applying force because of the feeling of foreign matter.Additional information received clarified that there was no foreign material present at any point.Reportedly, the soft tip of guidewire was slightly bent, and the coil of the guidewire was noted unwound upon removal from scope.The procedure was completed with another of the same device without patient complications.The patient outcome following the procedure was reported to be good.Investigation results revealed that the core wire was detached/separated.

• 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: 20464772
• Report Number: 2124215-2024-62772
• Device Sequence Number: 8767963
• Product Code: EZB
• UDI-Device Identifier: 08714729752660
• UDI-Public: 08714729752660
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2024

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: 01/10/2026
• Device Model Number: M0066401040
• Device Catalogue Number: 640-104S
• Device Lot Number: 0030833259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 11/20/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/07/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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
• Patient Sex: Unknown