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	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height: 164cm.E1 initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the tip was detached.Vascular access was obtained by puncturing the right femoral artery and the patient was placed in the supine position.A.035in 300cm back-up meier guidewire was selected for occlusion of the patent foramen ovale.However, the tip of the wire was found detached when it was unpacked.The procedure was completed with another of the same type of device.No complications were reported, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Patient height: 164cm.E1 initial reporter facility name: (b)(6) medical university.Device evaluated by mfr.: the device was returned for analysis.It was observed that the coil wire was unraveled due to the core wire being detached/separated from the distal tip to the transition point.Also, the guidewire was stretched and bent at the distal section.Based on the evidence, the reported allegation of distal tip detachment was confirmed.
Event or Problem Description
It was reported that the tip was detached.Vascular access was obtained by puncturing the right femoral artery and the patient was placed in the supine position.A.035in 300cm back-up meier guidewire was selected for occlusion of the patent foramen ovale.However, the tip of the wire was found detached when it was unpacked.The procedure was completed with another of the same type of device.No complications were reported, and the patient condition following procedure was stable.

• 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: 20250926
• Report Number: 2124215-2024-57137
• Device Sequence Number: 12989928
• 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): 11/14/2024

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: 09/21/2025
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0032488776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: 18 YR
• Patient Sex: Female
• Patient Weight: 58 KG