MAUDE Adverse Event Report: ABBOTT OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number LDA210Q/65

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

During an implant procedure, the stylet was difficult to advance into the right ventricular (rv) lead.Additionally, the helix of the rv lead had unspecified rotation issues.A new rv lead was used during the procedure and resolved the event.The patient was stable and will continue to be monitored.

Event Description

Additional information was received that the helix failed to retract during the procedure.

Manufacturer Narrative

The reported events of failure to advance the stylet and helix mechanism issue were confirmed.As received, a complete lead was returned in one piece.Visual inspection of the lead found the retracted helix clogged with blood.X-ray examination found a bent helix and an over torqued inner coil at the connector region.The helix mechanism and extension tests could not be performed due to a bent helix and an over torqued inner coil at the connector region, consistent with procedure damage.Electrical testing did not find any indication of conductor fractures or internal shorts.The cause of the reported event of a helix mechanism issue was due to blood clogging the helix at the helix region and an over torqued inner coil at the connector region.The cause of the reported event, failure to advance the stylet was due to an over torqued inner coil at the connector region.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17482624
• MDR Text Key: 320651182
• Report Number: 2017865-2023-37797
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: LDA210Q/65
• Device Lot Number: A000109001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/21/2023; 09/14/2023; 10/30/2023
• Supplement Dates FDA Received: 09/06/2023; 09/14/2023; 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1