FDA.reportPublic FDA data

MAUDE MDR 9824499

MDR report key
9824499
Report number
1036844-2020-00088
Event key
0
Event type
3
Date of event
2020-02-21
Date received
2020-03-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
EFFIE JEFFERSON
Address
3015 CARRINGTON MILL BLVD MORRISVILLE 27560 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EPIDURAL CATHETERIZATION KITANESTHESIA CONDUCTION CATHETERARROW INTERNATIONAL INC.BSOAK-0550323F19J0388R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-120

Event Narratives#

N

Patient 1

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

D

Patient 1

MEDWATCH # (B)(4). DESCRIPTION OF EVENT: (B)(6) 2020 AT 1345, EPIDURAL PLACED BY ANESTHESIOLOGIST: POSITIONED SITTING UPRIGHT, APPROACH MIDLINE, NEEDLE (# 17 GAUGE, PLACED VIA LOSS OF RESISTANCE TECHNIQUE (WITH AIR), CATHETER INSERTED INTO EPIDURAL SPACE:5 CM; INSERTION LEVEL: L3/4 ASPIRATION (NO PARESTHESIA NOTED, NOT BLOOD, NOT CEREBRAL SPINAL FLUID), INJECTANT (TEST DOSE GIVEN (LIDOCAINE 1.5% W/ EPINEPHRINE 1:200000, 3ML), NO CHANGE IN MATERNAL HR, NO SIGNS OF INTRAVASCULAR OR INTRATHECAL INJECTION WITH TEST DOSE). BABY DELIVERED VAGINALLY AT 1630. AT 1855, RN BEGAN REMOVING THE CATHETER WHEN SLIGHT RESISTANCE WAS MET. RN ASKED PATIENT TO REPOSITION AND ARCH BACK MORE TOWARDS RN TO AID WITH REMOVAL. RN AGAIN ATTEMPTED TO REMOVE CATHETER WITH LESS RESISTANCE NOTED FOLLOWING POSITION CHANGE. GENTLE TRACTION WAS APPLIED TO REMOVE THE CATHETER AND CATHETER BEGAN TO COME OUT WHEN RN NOTED THAT SOMETHING APPEARED ABNORMAL WITH THE EPIDURAL CATHETER. RN IMMEDIATELY STOPPED THE CATHETER REMOVAL AND CALLED THE IN-HOUSE CRNA TO COME AND EVALUATE THE EPIDURAL CATHETER. AT 1900 THE CRNA NOTED: THE PLASTIC MATERIAL OF CATHETER WAS FOUND TO BE BROKEN AT ABOUT THE 17 CM MARK WITH ONLY THE INTERNAL METALLIC WIRE REINFORCEMENT REMAINING CONNECTING THE BROKEN CATHETER TO THE REMAINING PORTION OF THE CATHETER INSIDE THE PATIENT. THE CRNA CALLED THE ANESTHESIOLOGIST WHO CAME TO THE BEDSIDE. PER THE ANESTHESIOLOGIST: 1913 "CALLED TO SEE PATIENT, EPIDURAL CATHETER NOT COMING OUT PROPERLY. WHEN I EXAMINED THE PATIENT UNSHEATHED WIRE PROTRUDING FROM PATIENT'S BACK WITH PROXIMAL EPIDURAL CATHETER ATTACHED. WITH APPLICATION OF MINIMAL TENSION SHORT SECTION OF WIRE CAME OUT OF SKIN WITHOUT TIP OF CATHETER PRESENT. NURSE REPORTED THAT EPIDURAL WAS SLIDING OUT ROUTINELY, WHEN IT SUDDENLY STOPPED, AND THE WIRE APPEARED. SHE IMMEDIATELY STOPPED AND CALLED US TO EVALUATE THE PATIENT. IT IS MY IMPRESSION THERE IS RESIDUAL CATHETER LEFT IN THE PATIENT. JUST HOW MUCH IS DIFFICULT TO JUDGE FROM THE FRAGMENT AVAILABLE FOR EXAM."