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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES HERMETIC LUMBAR CATHETER CLOSED TIP SPINAL DRAINAGE

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INTEGRA NEUROSCIENCES HERMETIC LUMBAR CATHETER CLOSED TIP SPINAL DRAINAGE Back to Search Results
Lot Number 1102268
Device Problems Guidewire (463); Material Frayed (1262); Difficult to Remove (1528); Physical Resistance (2578); Catheter (3038)
Patient Problem No Code Available (3191)
Event Date 10/20/2010
Event Type  Malfunction  
Event Description

This is a (b)(6) vasculopath that was having mesenteric bypass and required a spinal drain placed prior to surgery. Pt consented. She was laying on her right side. Sterile prep and drape. I placed the 14g tuoy needle in the l4-5 interspace and got csf return easily. I went to thread the catheter, which threaded easily. Then i was able to pull the needle back over the catheter. I never pushed the needle forwards once the catheter was in place. I then tried to pull the guidewire out. This was extremely difficult. With increased force i was able to pull the wire out but it did not come all the way out and frayed the end of the catheter, rendering it unusable. Ultimately, the case was cancelled because after this occurrence the pt requested not to undergo another attempt at her spinal drain. Kit: integra neurosciences hermetic lumbar catheter closed tip, lot# 1102268. Dose or amount: na. Dates of use: (b)(6) 2010. Diagnosis or reason for use: csf drainage. Event abated after use stopped or dose reduced? yes.

 
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Brand NameHERMETIC LUMBAR CATHETER CLOSED TIP
Type of DeviceSPINAL DRAINAGE
Manufacturer (Section D)
INTEGRA NEUROSCIENCES
311 enterprise dr
plainsboro NJ 08353 6
MDR Report Key1917643
MDR Text Key1654969
Report NumberMW5018453
Device Sequence Number1
Product Code JXG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/01/2014
Device LOT Number1102268
OTHER Device ID NumberINS 5010
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 12/02/2010 Patient Sequence Number: 1
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