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

Model Number	M0066401040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an amplatz super stiff was used in the procedure.When pushing the guidewire to mount onto the stent, the guidewire broke off after applying force due to the feeling of having a foreign matter.No patient complications were reported.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device problem code a0501 captures the reportable event of a core wire break.
Event or Problem Description
It was reported that an amplatz super stiff was used in the procedure.When pushing the guidewire to mount onto the stent, the guidewire broke off after applying force due to the feeling of having a foreign matter.No patient complications were reported.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Device problem code a0501 captures the reportable event of a core wire break.The returned amplatz guidewire was analyzed, and the evaluation found that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point.Also, the guidewire was kinked and bent at distal section.During product analysis it was found that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point, also, the guidewire was kinked and bent at distal section, it is related to excessive handling of the device and the technique used by the doctor in preparation, which could possibly have affected the performance and integrity of the device.The most probable cause code for the as reported code coil wire detachment of device or device component is "adverse event related to procedure.".
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Device problem code a0501 captures the reportable event of a core wire break.The returned amplatz guidewire was analyzed, and the evaluation found that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point.Also, the guidewire was kinked and bent at distal section.During product analysis it was found that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point, also, the guidewire was kinked and bent at distal section, it is related to excessive handling of the device and the technique used by the doctor in preparation, which could possibly have affected the performance and integrity of the device.The most probable cause code for the as reported code coil wire detachment of device or device component is "adverse event related to procedure".
Event or Problem Description
It was reported that, during a ureteroscopy procedure using an amplatz super stiff.When pushing the guidewire to mount onto the stent, the guidewire broke off after applying force.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 19940241
• Report Number: 2124215-2024-49107
• Device Sequence Number: 7340309
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

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 Model Number: M0066401040
• Device Catalogue Number: 640-104S
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 10/22/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/09/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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