FDA.reportPublic FDA data

MAUDE MDR 7154927

MDR report key
7154927
Report number
2648988-2017-00076
Event key
0
Event type
3
Date received
2017-12-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
102
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
USER KIMBERLY SHELLY
Address
311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LUMBAR CATHETERN/AINTEGRA NEUROSCIENCES PRHBGXXX-HERMETIC LUMBAR CATHETERR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-2901. O

Event Narratives#

N

Patient 1

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

D

Patient 1

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.