MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA MICRO VENTRICULAR BOLT ICP / TEMPERATURE MONITOR; N/A

Catalog Number 1104HMT

Device Problems Difficult or Delayed Positioning (1157); Device Difficult to Setup or Prepare (1487); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported that before the surgical procedure, the respective couplings (electrical current, cable pac-1) were made.The monitor was turned on without finding any difficulty or inconsistency.The surgical procedure begun and "cleaning" was performed; incision was made and the trepanation of the skull proceeded.When attaching the ventricular catheter with its respective screw, when fixing it to the skull, it was difficult to tie the catheter with the catheter system.It did not allow the catheter guide to leave.The catheter was removed from the patient together with the screw to verify if it can be threaded but it was difficult to tie the two sets of screws and catheter.The catheter was inserted with the screw but again at the moment of puncturing the ventricle, it was desired to remove the guide but it was not possible and it did not tie the screw to the catheter.It was tried a few times more but it was not possible to fix the screw and catheter in a suitable way, nor to remove the guide.The customer decided to open a new ventricular sensor in which the catheter was inserted, verified that it was in the ventricle, the screw was fixed to the skull of the patient and the guide was removed without any problem.There was no patient injury reported.

Manufacturer Narrative

Investigation completed 1/25/2018.The returned device was inspected and found no indication the catheter was inserted into the patient.Inspection of the introducer assembly discovered that the retaining cap tab was not align with the bolt slot causing a misalignment of the bolt and the bolt cap.The stylet was found protruding out of one of the drainage holes of the ventricular sleeve, however when an attempt to remove it from the assembly no problem was found and the stylet was completely removed.The retaining cap of the introducer assembly was realigned with the thread slot and the bolt and bolt cap threaded together with no issue.The device history record for the catheter was reviewed, there were no anomalies observed during the manufacturing, packaging or inspection of the device or accessories while in process.A potential root cause of the reported customer complaint can be attributed to the retaining cap coming out of the thread slot and causing a misalignment of the bolt and bolt cap threads.

• Brand Name: MICRO VENTRICULAR BOLT ICP / TEMPERATURE MONITOR
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• MDR Report Key: 6948891
• MDR Text Key: 90430466
• Report Number: 2023988-2017-00051
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1104HMT
• Device Lot Number: 111E00293416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1