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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
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.An.035 in, 300 cm back-up meier guidewire was prepared for an endovascular isolation of abdominal aortic aneurysm on the patient.When the device was taken out of its package, it was noted that the distal tip was detached from the guidewire.Another of the same device was used in completing the procedure.No complications were reported, and the patient was in a stable condition.
Event or Problem Description
It was reported that tip detachment occurred.An.035 in, 300 cm back-up meier guidewire was prepared for an endovascular isolation of abdominal aortic aneurysm on the patient.When the device was taken out of its package, it was noted that the distal tip was detached from the guidewire.Another of the same device was used in completing the procedure.No complications were reported, and the patient was in a stable condition.
Additional Manufacturer Narrative
**udi related data quality updates only** this report is being filed as a correction in response to an fda request.This product is not approved in the united states, however, it has been assessed as reportable as there is a similar product approved in the united states.We have not provided the unique identifier (udi) # and other specific product information related to united states registration as the specific product is only commercially available outside of the united states.Manufacturer analysis: it was observed that the device was bent/kinked, unraveled and the core wire was detached.Consequently, the reported complaint event distal tip "detachment of device or device component" is confirmed due to the device condition.E1: initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that tip detachment occurred.An.035 in, 300 cm back-up meier guidewire was prepared for an endovascular isolation of abdominal aortic aneurysm on the patient.When the device was taken out of its package, it was noted that the distal tip was detached from the guidewire.Another of the same device was used in completing the procedure.No complications were reported, and the patient was in a stable condition.
Additional Manufacturer Narrative
Corrected fields: e1 - initial reporter phone.Manufacturer analysis: it was observed that the device was bent/kinked, unraveled and the core wire was detached.Consequently, the reported complaint event distal tip "detachment of device or device component" is confirmed due the device condition.E1: initial reporter facility name: (b)(6).

• 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: 18234134
• Report Number: 2124215-2023-66362
• Device Sequence Number: 12496783
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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: 04/24/2025
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0031497498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 07/08/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/05/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG