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

Model Number	39575
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was observed.The target lesion was located in a not very tortuous and non-calcified vessel.A 035/260 amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the guidewire would not load into catheter due to some foreign material on it.The procedure was completed with a different amplatz guidewire.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Good faith effort attempts were made to try and retrieve the device lot number, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that foreign material was observed.The target lesion was located in a not very tortuous and non-calcified vessel.A 035/260 amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the guidewire would not load into catheter due to some foreign material on it.The procedure was completed with a different amplatz guidewire.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the reported guidewire was returned to our post market quality assurance laboratory.Visual inspection was performed, and it was observed that the distal tip was bent.No foreign material was observed in the device.Detailed product information was not provided to bsc.Good faith effort attempts were made to try and retrieve the device lot number, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• 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 DE COSTA RICA S.R.L.
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21865727
• Report Number: 2124215-2025-23290
• Device Sequence Number: 4719203
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• UDI-Public: (01)08714729115830
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K843016
• 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
• Report Date (Section B): 06/09/2025

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
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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