MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Fracture (1260)

Patient Problem Vertebral Fracture (4520)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

Initial implantation experienced a guidewire break and all parts were removed and a second attempt was made to implant a new device.The second attempt experienced resistance and was aborted without any issue.Patient was closed without a barricaid implant.

Manufacturer Narrative

A company representative who was present for the implantation provided images that show the implant was hiting an obstruction.This obstruction caused additional force on the guide wire which subsequently broke.There is no risk to the patient according to our hha.

• 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: 15869502
• MDR Text Key: 307817370
• Report Number: 3006232063-2022-00013
• 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 Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 04302118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention