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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES CORPORATION HERMETIC LUMBAR CATHETER TIP SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
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.
 
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Brand NameHERMETIC LUMBAR CATHETER TIP
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
11 cabot blvd.
mansfield MA 02048
MDR Report Key8183984
MDR Text Key130992656
Report Number8183984
Device Sequence Number1
Product Code JXG
UDI-Device Identifier10381780071082
UDI-Public(01)10381780071082
Combination Product (y/n)N
Number of Events Reported1
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 Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINS5010
Device Catalogue NumberINS5010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2018
Event Location Hospital
Date Report to Manufacturer12/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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