MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA OLM INTRACRANIAL PRESSURE MONITORING KIT; N/A

Catalog Number 1104B

Device Problems Bent (1059); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Four patients presented with very high intracranial pressure (icp) readings (60-80mmhg) post implantation.These reading were not accepted by the neurosurgeons.The patients were sent for ct scan/magnetic resonance imaging and appeared to have "plenty of space." upon removal, one of the 110-4b catheters was found to be "bent." the issue increased the time for following patient pressure.Additional information received on 24jan2017 with the following: the patient for this particular report is a (b)(6) male patient with head trauma.The catheter was placed between (b)(6) 2017.Icp was elevated.The icp monitor was changed multiple times.The catheter was not retained.There was no patient injury reported.No patient injured the following lot numbers for the 1104-bt catheters have been used recently and one of these could have been used on this patient: lot numbers: 111e00227069, 111e00279658, or 111e00279816.Linked to mfg.Report numbers: 2023988-2017-00005, 2023988-2017-00007, 2023988-2017-00008, 3006697299-2017-00018, 3006697299-2017-00019, 3006697299-2017-00020, 3006697299-2017-00021, 3006697299-2017-00022, 3006697299-2017-00023, 3006697299-2017-00024, 3006697299-2017-00025.

Manufacturer Narrative

Investigation completed 3/07/17.Method: -dhr review, -trend analysis.The catheter has not been returned for investigation.Three lots have been used recently at the customer facility; they met specifications before released to finished goods: (b)(6).Complaint history, model 110-4xxx, from feb-2016 through jan-2017 reviewed; there were three other complaints that issued with complaint code perf033, and none of them was confirmed.The number of confirmed reports (0 ) divided by the number of units sold model 110-4xxx, (b)(4) multiplied by 100 results in a failure rate percentage (b)(4).Conclusion: the customer¿s complaint ¿ could not be confirmed since the customer did not return the catheter for evaluation ("catheter not retained").The device history records for the possible lot numbers the customer reported were reviewed did not reveal any anomalies observed during the manufacturing, packaging or inspection of the device or accessories while in process.Additionally, because the product was not returned for evaluation, no root cause could be established for the failure mode described in the customer complaint.

• Brand Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6300319
• MDR Text Key: 66768465
• Report Number: 2023988-2017-00006
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1104B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR