MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BACK-UP MEIER; WIRE, GUIDE, CATHETER

Model Number	41488
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on 15jul2025.It was reported that stretched tip occurred.The target lesion was located in the abdominal aorta.A.035in, 300cm back-up meier guidewire was selected for use.During preparation and prior to administering anesthesia, the tip was observed to be stretched upon unpacking.The procedure was not completed.There were no patient complications as a result of this event and the patient status was stable.However, returned analysis revealed a detached corewire.
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6).The device was returned for analysis.Upon visual examination of the amplatz device, it was observed that the distal tip was stretched, the core wire was detached, and the distal tip was kinked.

• Brand Name: BACK-UP MEIER
• 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: 22793439
• Report Number: 2124215-2025-54780
• Device Sequence Number: 8643453
• Product Code: DQX
• UDI-Device Identifier: 08714729227908
• UDI-Public: (01)08714729227908(17)260715(10)34437216
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020283
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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 Expiration Date: 07/15/2026
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0034437216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 70 KG