MAUDE Adverse Event Report: MONTERIS MEDICAL 3.3MM MINI-BOLT VUE

Model Number	21133
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an ablation procedure, it was reported that the user attempted to remove the ceramic mini-bolt vue bolt using the insertion driver & blue insertion driver adapter.The interface between the vue adapter & ceramic bolt became stripped during the process, so the surgeon attempted to remove the bolt using a surgical clamp rather than using the provided removal tool.While attempting to remove the bolt with the surgical clamp, the ceramic bolt broke apart where the clamp was contacting the bolt.The surgeon was then required to drill out the bolt.
Additional Manufacturer Narrative
The mini-bolt bue insertion adapter is designed to be torque-limiting to prevent damage to the mini-bolt vue during insertion.A separate titanium mini-bolt removal tool is provided by monteris for removal of the mini-bolt vue and is indicated in the mini-bolt instructions for use (ifu internal part number: 80437).The mini-bolt & mini-bolt vue are not designed to be removed with surgical clamps or other surgical instruments, and use of such tools for mini-bolt vue removal is not indicated in the ifu.It should also be noted that the surgeon indicated the patient suffered no additional comorbidities due to this event.
Additional Manufacturer Narrative
This supplemental report updates section h1 to indicate "serious injury" instead of "malfunction" based on reassessment.Additionally, the health effect - clinical code and impact code were corrected.It is to note that following the clinical code "device embedded in tissue or plaque", the device was successfully removed with surgical excision.Other information in the original report remains accurate.
Event or Problem Description
During an ablation procedure, it was reported that the user attempted to remove the ceramic mini-bolt vue bolt using the insertion driver & blue insertion driver adapter.The interface between the vue adapter & ceramic bolt became stripped during the process, so the surgeon attempted to remove the bolt using a surgical clamp rather than using the provided removal tool.While attempting to remove the bolt with the surgical clamp, the ceramic bolt broke apart where the clamp was contacting the bolt.The surgeon was then required to drill out the bolt.

• Brand Name: 3.3MM MINI-BOLT VUE
• Common Device Name: 3.3MM MINI-BOLT VUE
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer (Section G): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: dan hoseck ; 131 cheshire ln; suite 100; minnetonka, MN 55305 ; 8667997655
• MDR Report Key: 15969011
• Report Number: 3009970070-2022-00038
• Device Sequence Number: 4951794
• Product Code: HAO
• UDI-Device Identifier: 00816589021233
• UDI-Public: 00816589021233
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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 Expiration Date: 04/29/2025
• Device Model Number: 21133
• Device Catalogue Number: CMB033-V
• Device Lot Number: 8379601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown