MAUDE Adverse Event Report: ABBOTT TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number	2088TC/100
Medical Device Problem Codes	Fitting Problem (2183); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During attempted implant, the guidewire could not be inserted into the body of the left ventricular (lv) lead.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 insert the guidewire was confirmed.As received, a complete lead was returned in one piece with the helix retracted and clogged blood/tissue.The lead was evaluated with the stylet and found restriction/obstruction at the proximal region of the lead.Further analysis found the inner coil clogged with blood.The cause of the reported event was isolated to the inner coil clogged with blood.

• Brand Name: TENDRIL STS
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15505213
• Report Number: 2017865-2022-39761
• Device Sequence Number: 17496547
• Product Code: NVN
• UDI-Device Identifier: 05414734505031
• UDI-Public: 05414734505031
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 2088TC/100
• Device Catalogue Number: 2088TC-100
• Device Lot Number: P000143184
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 06/14/2023
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/07/2022; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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