LUMBAR CATHETER XXX-HERMETIC LUMBAR CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-01-02 for LUMBAR CATHETER XXX-HERMETIC LUMBAR CATHETER manufactured by Integra Lifesciences Corp.

Event Text Entries

[96149481] The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[96149482] This report is for the first patient who suffered from csf leak after drain removal. 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 sample 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: 2648988-2017-00075 and 2648988-2017-00076.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648988-2017-00074
MDR Report Key7156623
Report SourceLITERATURE
Date Received2018-01-02
Date of Report2017-12-06
Date Mfgr Received2018-07-26
Date Added to Maude2018-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTAL HYGIENIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA NEUROSCIENCES PR
Manufacturer StreetROAD 402 NORTH, KM 1.2
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLUMBAR CATHETER
Generic NameN/A
Product CodeHBG
Date Received2018-01-02
Catalog NumberXXX-HERMETIC LUMBAR CATHETER
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP
Manufacturer Address311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-01-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.