MAUDE Adverse Event Report: ABBOTT TENDRIL STS; NO MATCH

Model Number 2088TC/52

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult to Advance (2920)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

During an initial implant procedure, the helix was not able to extend and it was difficult to advance the stylet into the right atrial (ra) lead was being implanted.A new ra lead was used to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events of helix mechanism issue and failure to advance the stylet were confirmed.As received, a complete lead was returned in one piece with the helix found extended and clogged with blood.X-ray inspection found the inner coil was over torqued at the connector region consistent with procedural damage.The stylet insertion test was unable to be performed due to the over torqued inner coil at the connector region.The cause of the reported events was due to over torqued of the inner coil and helix being clogged blood/tissue.Electrical testing did not find any indication of conductor fractures however an internal short was noted between conductor paths due to overtorqued inner coil inside the connector region.

• Brand Name: TENDRIL STS
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18514974
• MDR Text Key: 332867766
• Report Number: 2017865-2024-01031
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P960013
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/52
• Device Lot Number: P000187239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• 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