MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION HERMETIC LUMBAR CATHETER TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS5010

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2018

Event Type  Injury  

Event Description

The lumbar area was prepped and draped in the usual sterile fashion.Using landmarks, l3-4 was accessed with a 20g quinke needle to identify spinal space.Subsequently a 14g touhy needle was placed on first attempt and clear csf fluid drained appropriately.The catheter with wire stylet was inserted without problems.Wire removal was attempted but there was resistance met.Because of this resistance, the touhy needle,lumbar spinal catheter, and wire stylet were all removed at the same time.It was noted that the tip of the lumbar spine catheter was missing.Patient has a stable neuro exam at this time and vss.Stat spine ct was obtained.Neurosurg stat consulted.Patient currently in icu stable.Procedure details: sterility: chloraprep.Lumbar space: l3-l4 interspace.Patient's position: sitting.Needle gauge: 14.Number of attempts: 1.Fluid appearance: clear.

• Brand Name: HERMETIC LUMBAR CATHETER TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 8183984
• MDR Text Key: 130992656
• Report Number: 8183984
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: (01)10381780071082
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS5010
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 21170 DA
• Patient Weight: 114