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

Model Number	41488
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the abdominal aorta.A.035in, 300cm ex/c tip b/5 back-up meier guidewire was selected for use.During unpacking, it was noted that the guidewire was unwinding at its tip and the wire of the shaft was visually fractured.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) university.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).The guidewire was returned, and it was observed that the device was bent and stretched at transition distal.Based on analysis of the returned product, the reported detachment allegation could not be confirmed due to lack of evidence and the reported tip damage is confirmed as the device was bent and stretched at transition distal.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the abdominal aorta.A.035in, 300cm ex/c tip b/5 back-up meier guidewire was selected for use.During unpacking, it was noted that the guidewire was unwinding at its tip and the wire of the shaft was visually fractured.The procedure was completed with another of the same device.No complications were reported, and the 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19093379
• Report Number: 2124215-2024-18448
• Device Sequence Number: 12687465
• Product Code: DQX
• UDI-Device Identifier: 08714729227908
• UDI-Public: 08714729227908
• 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,Followup
• Report Date (Section B): 05/22/2024

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: 07/30/2025
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0032123920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 78 KG