MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

An 8mm barricaid implantation was performed.After the procedure was completed and the patient's skin incision was closed, it was noticed upon review of the intra-operative fluoroscopic images that the nitinol mesh guide had fractured and separated from the pusher during implantation.As this was not noticed during the procedure, the fractured mesh guide still resided in the polymer barrier of the implant in the patient.On (b)(6) 2022, a reoperation was performed to remove the fractured mesh guide without incident.

Manufacturer Narrative

Based on the surgeon narrative and imaging, it was confirmed that mesh guide detachment had occurred during implantation and that the fractured mesh guide remained within the implant at the close of surgery.No deviations or non-conformances were noted in the lot history review.The fluorographs provided evidence that the positioning of the delivery instrument rotated during the implantation.This change in orientation may have been related to the root cause for the mesh guide fracture.

• Brand Name: BARRICAID ACD
• Type of Device: BARRICAID
• Manufacturer (Section D): INTRINSIC THERAPEUTICS, INC; 30 commerce way; woburn MA 01801
• Manufacturer (Section G): INTRINSIC THERAPEUTICS, INC; 30 commerce way; woburn MA 01801
• Manufacturer Contact: rachael nelsen ; 30 commerce way; woburn, MA 01801 ; 7819320222
• MDR Report Key: 15872914
• MDR Text Key: 307816229
• Report Number: 3006232063-2022-00012
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA88MM0
• UDI-Public: M906BARA88MM0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160050
• 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
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 04302117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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
• Patient Outcome(s): Required Intervention