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

Model Number	M0066401060
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the metal coating on the wire un-wound and got stuck in the patient it was attempted to remove it but it was too difficult.Therefore, a following procedure will be performed to remove the part of the device.The procedure was completed using an alternative method and there were no patient complications reported.
Event or Problem Description
It was reported that during the procedure, the metal coating on the wire un-wound and got stuck in the patient it was attempted to remove it but it was too difficult.Therefore, a following procedure will be performed to remove the part of the device.The procedure was completed using an alternative method and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil wire detachment of device or device component.Imdrf f1901 captures the reportable impact code of additional surgery.Block h11: upon receipt at our quality assurance laboratory, this amplatz super stiff guidewire underwent a thorough analysis.The device was visually examined and the reported observation could be confirmed.It was observed that the core wire was found separated from the bald weld and was stretched and bent at distal section, moreover the tip was detached.It is related to excessive handling of the device and the technique used by the doctor in procedure, which could possibly have affected the performance and integrity of the device.Additional surgery, will be classified as adverse event related to procedure as this was a consequence of coil wire detachment of device or device component and device difficult to remove.All necessary inspection was performed to ensure the integrity of the device for its used.Based on the information available and investigation results, a conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure, the metal coating on the wire un-wound and got stuck in the patient it was attempted to remove it but it was too difficult.Therefore, a following procedure will be performed to remove the part of the device.The procedure was completed using an alternative method and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil wire detachment of device or device component.Imdrf f1901 captures the reportable impact code of additional surgery.Block h11: upon receipt at our quality assurance laboratory, this amplatz super stiff guidewire underwent a thorough analysis.The device was visually examined, and the reported observation could be confirmed.It was observed that the core wire was found separated from the bald weld and was stretched and bent at distal section, moreover the tip was detached.It is related to excessive handling of the device and the technique used by the doctor in procedure, which could possibly have affected the performance and integrity of the device.Additional surgery will be classified as adverse event related to procedure as this was a consequence of coil wire detachment of device or device component and device difficult to remove.All necessary inspection was performed to ensure the integrity of the device for its used.Based on the information available and investigation results, a conclusion code of adverse event related to procedure was assigned to this investigation.Block h11: the complaint device was returned for analysis; it was observed that the core wire was found separated from the bald weld.Also, the guidewire was stretched and bent at distal section, moreover the tip was detached.A risk review was completed and confirmed that the event of additional surgery, coil wire detachment of device or device component and device difficult to removed were defined in the risk documentation and is documented accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Therefore, these issues will be classified as adverse event related to procedure.

• 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: 21027930
• Report Number: 2124215-2024-82074
• Device Sequence Number: 9004171
• Product Code: EZB
• UDI-Device Identifier: 08714729752684
• UDI-Public: 08714729752684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0066401060
• Device Catalogue Number: M0066401060
• Device Lot Number: 0034108186
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/30/2025; 03/24/2026
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/20/2025; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown