MAUDE Adverse Event Report: ABBOTT MEDICAL TUNNELING TOOL, 20"; SCS TUNNELING TOOL

Model Number	1120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a implant procedure on (b)(6) 2023 the tunneling tool sheath was bunched up damaged and split while in use.As such, the physician made an incision to remove the pieces that were stuck inside of the patient.All broken pieces were removed and the procedure was completed.
Additional Manufacturer Narrative
A case of sheath bunched during implant was reported to abbott.On 18may2023 rep emailed that during a cervical permanent implant a 20¿ tunneling tool sheath was bunched up damaged and split while in use.The physician had to make an incision to remove the pieces that was stuck inside of the patient.All broken pieces were removed, and the case proceeded.The device will not be returned due to hospital policy.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

• Brand Name: TUNNELING TOOL, 20"
• Common Device Name: SCS TUNNELING TOOL
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17101909
• Report Number: 1627487-2023-02771
• Device Sequence Number: 13950354
• Product Code: LGW
• UDI-Device Identifier: 05414734400176
• UDI-Public: 05414734400176
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: 1120
• Device Catalogue Number: 1120
• Device Lot Number: 8050535
• Was Device Available for Evaluation?: No
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/10/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 71 KG