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

Model Number MN13650

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/14/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 314710488
• Report Number: 1627487-2023-02068
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025616
• UDI-Public: 05415067025616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DRG LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 113 KG