MAUDE Adverse Event Report: RAUMEDIC AG NEUROVENT-PTO; NEUROLOGICAL CATHETER

Model Number 095008-002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

Summary of the event from the manufacturer's perspective and the investigations and interviews conducted: manufacturing documents of the corresponding catheter and bolt drill kit were checked and found to be correct.The further investigations and interviews with the clinic have shown that the catheter and bolt were destroyed by massive stress by a procedure that have had nothing to do with using of the catheter and bolt that was actually the subject of this complaint.Therefore, a normal explantation of the catheter and bolt were no longer possible and, as a result, a serious injury was caused by an additional surgical procedure.There is no evidence that the catheter or bolt kit have had a malfunction.

Event Description

From our distributor we received the following decription of an event to one of our catheter neurovent-pto and the corresponding application accessorie bolt kit pto.Complaint report from clinic: "the patient had a right frontal raumedic monitor and we were going to place a right sided evd just behind the monitor site.The monitor was giving some low reading prior to the evd even being placed, so we had planned to replace the raumedic monitor during the same procedure.During the replacement process the tip of the catheter was noted to be broken inside of the peek bolt.There was an additional procedure required to retrieve the broken piece.This occurred while the provider was placing an additional evd into the patient.It is unclear if this was related to technique or a product malfunction.".After further request to the clinic we received the following additional description to the event: "the patient was very critical.He sustained a fall which led to an intracranial hemorrhage.He was taken for emergent surgery.The raumedic catheter was planned on day of admission post operatively.An evd was placed to help treat patients elevated icps later that day.During external ventricular drain placement, raumedic icp levels were fluctuating between being present and absent.After evd insertion, we decided to switch raumedic catheter under sterile conditions but after removal noticed the raumedic catheter cut.No visible remnants were seen to naked eye and it was suspected remnant catheter ~2cm in length was left in the brain.The raumedic bolt was then removed.It was seen severed toward the tip.The burr hole for the evd had been created by an electronic driven hand drill.It was placed approximately 1cm behind the raumedic bolt site.It's certainly possible that the drill hit the raumedic bolt.It doesnt make a lot of sense why the catheter would be severed in half at that depth though.All catheters including the remnant piece of catheter were removed from the patient.".

• Brand Name: NEUROVENT-PTO
• Type of Device: NEUROLOGICAL CATHETER
• Manufacturer (Section D): RAUMEDIC AG; am mühlgraben 10; zwönitz, 08297 ; GM 08297
• Manufacturer (Section G): RAUMEDIC AG; am mühlgraben 10; zwönitz, 08297 ; GM 08297
• Manufacturer Contact: hannes engelhardt ; am muehlgraben 10; zwoenitz, 08297 ; GM 08297
• MDR Report Key: 18757323
• MDR Text Key: 335990953
• Report Number: 3006942548-2024-00003
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 095008-002
• Device Catalogue Number: 095008-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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