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

Model Number 7122Q/58

Device Problems Retraction Problem (1536); Low impedance (2285); Capturing Problem (2891)

Patient Problem Cardiac Perforation (2513)

Event Date 06/29/2023

Event Type  Injury  

Event Description

During an in clinic follow up, low pacing impedance and an increased threshold were observed on the right ventricular (rv) lead.Diagnostic imaging was performed and a cardiac perforation was observed.A pericardial drainage was performed and the rv lead was attempted to be repositioned however, the helix was unable to be retracted.The rv lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events were cardiac perforation, high pacing threshold, low pacing lead impedance and helix mechanism issue.As received, a complete lead was returned in one piece.Visual inspection of the lead found the helix to be extended within specification and was clogged with blood/tissue as received.The reported events of high pacing threshold and low pacing lead impedance were not confirmed while the reported event of helix mechanism was confirmed.X-ray examination found the inner coil was over torqued consistent with procedural damage.After cleaning blood/tissue from the helix and applying torque to the connector pin, the helix could be retracted and extended.The full measured helix extension length was within specification.The cause of the reported event of helix mechanism issue was isolated to the helix being clogged with blood/tissue and over torque of the inner coil.Electrical tests and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies.Tip stiffness test was performed and results were within specification.

• Brand Name: DURATA STS OPTIM 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: 17298881
• MDR Text Key: 318825615
• Report Number: 2017865-2023-35531
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• 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
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000133199
• 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: 06/29/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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
• Patient Outcome(s): Required Intervention