MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Back-Up Meier; wire, guide, catheter

Model Number	41488
Medical Device Problem Codes	Nonstandard Device (1420); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the interatrial.A.035in, 300cm back-up meier was selected for use.However, during unpacking, it was noted that the end of the guidewire was separated.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital the guidewire was returned, and it was observed that the coil wire was unraveled, and the core wire was found detached from the distal tip to the transition point.Also, the guidewire was kinked and bent at the distal section.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the interatrial vasculature.A.035in, 300cm back-up meier was selected for use.However, during unpacking, it was noted that the end of the guidewire was separated.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 19585587
• Report Number: 2124215-2024-36111
• Device Sequence Number: 3530168
• Product Code: DQX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 09/19/2025
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0032469291
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/08/2024; Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 57 LB