MAUDE Adverse Event Report: ABBOTT MEDICAL KIT BIG CURVE DELIVERY SHEATH; DRG BIG CURVE SHEATH

Model Number	MN13650
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a drg trial procedure on (b)(6) 2023 there was a complication with the drg big curve sheath.The physician was trying to advance the sheath towards the target location at the right l5 drg when he was having trouble directing it.He removed the sheath and guide wire from the epidural needle, and when he did the distal end of the big curve sheath broke off and remained in the patient.When the sheath was removed it was clearly visible that a part of it was missing.This was also confirmed with x-ray imaging showing the radiopaque distal tip of the sheath.It was also confirmed with lateral x-ray imaging that this piece was not in the epidural space.It was posterior to the lamina at that spine level.The trial physician did not have the means to retrieve it, and it was abandoned inside the patient.The procedure was still completed as planned, and the patient did not appear to have any further complications.
Additional Manufacturer Narrative
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.

• Brand Name: KIT BIG CURVE DELIVERY SHEATH
• Common Device Name: DRG BIG CURVE SHEATH
• 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: 16880819
• Report Number: 1627487-2023-02068
• Device Sequence Number: 12578272
• Product Code: PMP
• UDI-Device Identifier: 05415067025616
• UDI-Public: 05415067025616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• 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): 06/21/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MN13650
• Device Catalogue Number: MN13650
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DRG LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 113 KG