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

Model Number	41488
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.During unpacking of a.035in, 300cm ex/c tip b/5 back-up meier guidewire, it was found that the tip of the wire was unscrewed.The procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.
Additional Manufacturer Narrative
E1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection revealed the distal tip was bent, detached and unraveled.The ptfe was torn.No further damages were observed.
Event or Problem Description
It was reported that tip detachment occurred.During unpacking of a.035in, 300cm ex/c tip b/5 back-up meier guidewire, it was found that the tip of the wire was unscrewed.The procedure was completed with another of the same device.There were no patient complications reported, and the patient status 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: 17352273
• Report Number: 2124215-2023-35853
• Device Sequence Number: 5466972
• 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
• Report Date (Section B): 09/18/2023

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: 04/14/2025
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0031432081
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2023
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG