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

Model Number	41488
Medical Device Problem Codes	Stretched (1601); Difficult to Open or Remove Packaging Material (2922); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29feb2024.A 260 cm.035 w/c tip back-up meier guidewire was selected for use.Upon unpacking, the device could not be pulled from the back end.After the tip of the wire was out, it was found stretched and could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.However, device analysis revealed that the guidewire tip was detached from the bald weld.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for the analysis.It was possible to see that the guidewire was stretched at the distal tip and coil wire sections.Additionally, it was discovered that the tip was detached from the bald weld.

• 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: 18982270
• Report Number: 2124215-2024-17707
• Device Sequence Number: 8381818
• Product Code: DQX
• UDI-Device Identifier: 08714729455790
• UDI-Public: 08714729455790
• 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): 03/26/2024

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 Expiration Date: 10/19/2025
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0032687287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 58 KG