MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39575
Medical Device Problem Codes	Unraveled Material (1664); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 18jul2025.It was reported that the guidewire was unable to advance and became unraveled.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the guidewire could not move advance in the lesion.The device was removed, and it was noted that the guidewire has become loose.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed that the core wire was detached.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the distal tip was stretched, moreover the core wire was detached, and the spring tip was unraveled.No other issues were identified during the product analysis.There is a picture attached in the parent record, it was possible to observed that the device was stretched.No other issues were identified with the device.
Additional Manufacturer Narrative
E1 - initial reporter phone: updated.E1 - initial reporter email: updated.Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the distal tip was stretched, moreover the core wire was detached, and the spring tip was unraveled.No other issues were identified during the product analysis.There is a picture attached in the parent record, it was possible to observed that the device was stretched.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 18jul2025.It was reported that the guidewire was unable to advance and became unraveled.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the guidewire could not move advance in the lesion.The device was removed, and it was noted that the guidewire has become loose.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed that the core wire was detached.The device was returned for evaluation.Visual inspection revealed that the distal tip was stretched, moreover the core wire was detached, and the spring tip was unraveled.No other issues were identified during the product analysis.There is a picture attached in the parent record, it was possible to observed that the device was stretched.No other issues were identified with the device.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22806874
• Report Number: 2124215-2025-55375
• Device Sequence Number: 20783015
• Product Code: DQX
• UDI-Device Identifier: 08714729295747
• UDI-Public: (01)08714729295747
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K843015
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0035386097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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
• Patient Sex: Unknown