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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LUMBAR CATHETER N/A

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INTEGRA NEUROSCIENCES PR LUMBAR CATHETER N/A Back to Search Results
Catalog Number XXX-HERMETIC LUMBAR CATHETER
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Headache, Lumbar Puncture (2186)
Event Type  Injury  
Manufacturer Narrative
Additional information received on 26jul2018 indicating that a (b)(6) female patient was inserted with a drain on the day of the surgery. The cerebrospinal fluid (csf) was drained for 2 days and the drain was removed on "pod 2".
 
Event Description
N/a.
 
Manufacturer Narrative
Investigation completed on 01/17/2018. The events were not attributed to the use of the device in the evaluated report (no product failure was reported); no lot number was reported for documentation review; and no units were returned to confirm the complaint. No further investigation is possible; the root cause for these events is undetermined.
 
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
This report is for the last patient who developed a postoperative dural puncture headache on the postoperative day. Anesthesia analgesia (2017) published fluoroscopic-guided lumbar spinal drain insertion for thoracic aortic aneurysm surgery which studies csf drainage in taaa open and endovascular repair to aid in the prevention and management of sci. This report discussed 3 patients samples who developed mild postoperative complications related to spinal drain management of sci. First, patient suffered from csf leak after drain removal that resolved spontaneously after 4 hours of keeping flat and avoiding head elevation greater than 30 degree. Second, blood-tinged pink csf was observed in another patient in the immediate postoperative period. The last patient developed a postoperative dural puncture headache on the postoperative day. The study concluded that fluoroscopic-guided spinal drain insertion by interventional neuroradiologists using fluoroscopy can be a backup for anesthesiologists when they face difficult or failed drain insertions, and they can also be used in patients with known coagulopathy. Two patients within this case series had their drains inserted on the first postoperative day, as opposed to the pre-operative period, for management of postoperative paralysis. One patient presented for an emergency thoracic endovascular aortic aneurysm repair (tevar) for ruptured taaa, and we were not able to insert a drain preoperatively. The second patient underwent fenestrated endovascular aortic repair (fevar) for treatment of abdominal aortic aneurysm. Because he was considered low risk for the development of sci, the drain was not inserted preoperatively. Both patients were referred to the intervention neuroradiologist for lumbar spinal drain insertion because of coagulopathy (platelet count: 97,000 cell/ ul; international normalized ratio: 1. 4 and 1. 5 for patients 1 and 2, respectively. Linked to mfg report numbers: 2648988-2017-00074 and 2648988-2017-00075.
 
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Brand NameLUMBAR CATHETER
Type of DeviceN/A
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR 00610
Manufacturer (Section G)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
anasco PR 00610
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7154927
MDR Text Key248665889
Report Number2648988-2017-00076
Device Sequence Number1
Product Code HBG
Combination Product (y/n)N
PMA/PMN Number
K961113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Dental Hygienist
Type of Report Initial,Followup,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-HERMETIC LUMBAR CATHETER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
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 Unkown

Patient Treatment Data
Date Received: 12/29/2017 Patient Sequence Number: 1
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