MAUDE Adverse Event Report: ABBOTT TENDRIL STS; NO MATCH

Model Number	2088TC/100
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an elective replacement procedure, it was not possible to retract the helix on the left ventricular (lv) lead.Lv helix damage was alleged.As a result, the lv lead was explanted to resolve the event.The patient was stable.
Event or Problem Description
Additional information was received that there is lead damage that was confirmed visually.
Additional Manufacturer Narrative
The reported events of ¿the electrode tip came loose¿ and helix mechanism issue were confirmed.As received, a complete lead was returned in two pieces with the helix found extended and clogged with blood/tissue.Visual inspection found the connector pin was broken / separated from the connector assembly consistent with procedural damage.After cutting and cleaning the distal end of the lead, the helix could be retracted and extended by applying torque directly to the inner coil.The full helix extension length was measured within specification.The cause of the reported events was due to the helix being clogged with blood/tissue and excessive forces resulted in the connector pin to be pulled out of the connector assembly consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: TENDRIL STS
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19237678
• Report Number: 2017865-2024-40179
• Device Sequence Number: 12761610
• Product Code: NVN
• UDI-Device Identifier: 05414734505031
• UDI-Public: (01)05414734505031(10)P000193548(17)270131
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2024

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: 2088TC/100
• Device Lot Number: P000193548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 06/06/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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