MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number	1458QL/75
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During attempted implant, the left ventricular (lv) lead could not be inserted into the guidewire.A different guidewire was used; the lv lead could not be advanced.A different lv lead was successfully implanted to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of inability to advance the guidewire was confirmed.As received, a complete lead was returned in one piece.Visual inspection of the lead found the inner coil was offset at the distal region of the lead consistent with procedural damage.The stylet insertion test could not be performed due to the offset inner coil inside the distal region.The cause of the reported event was consistent with procedural damage.The s-curve height was measured to be within specification.

• Brand Name: QUARTET
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22119174
• Report Number: 2017865-2025-75154
• Device Sequence Number: 15247732
• Product Code: NIK
• UDI-Device Identifier: 05414734510202
• UDI-Public: (01)05414734510202(10)A000154447(17)270228
• Combination Product (Y/N): Y
• Initial Reporter Country: SI
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Model Number: 1458QL/75
• Device Lot Number: A000154447
• Was Device Available for Evaluation?: No
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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 Sex: Unknown