ARROW FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT AK-05503

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for ARROW FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT AK-05503 manufactured by Teleflex Medical.

Event Text Entries

[183729968] Event: epidural catheter tip broke off and retained in patient. Description of event: [date redacted] 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 parasthesias 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 pt, epidural cath not coming out properly. When i examined pt unsheathed wire protruding from pt's back with proximal epidural cath 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. " x-ray shows: curvilinear foreign body (approximately 5 cm segment) projecting over the posterior aspect of l1-2 and expected spinal canal. Ct shows: portion of the epidural catheter is visualized entering the epidural space just to the left of midline at the level of l1-l2. The tip of the catheter fragment is approximately 4. 4 cm from the skin surface. Approximately 3. 3 cm of the catheter extends posteriorly from the epidural space. Within the epidural space the catheter coils superiorly and to the left with the distal tip near the midline at the level of l1. Small amount of soft tissue gas posterior to l1. On (b)(6) 2020 patient going to surgery to have broken catheter removed. In operating room, md made skin incision and was right away able to see about 10 cm of coiled up wires right in the middle of the incision. Per the surgeon, "i dissected down to superior of the spinous processes of l1 and l2 and again blunt and sharp dissection, i dissected around the catheter and i actually reach the main catheter. At that time, i opened the fascia on both sides, more on the left side and i held the catheters and then i was able to actually pull it out without any resistance. I did not need to do any laminectomy. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9841113
MDR Report Key9841113
Date Received2020-03-17
Date of Report2020-02-05
Date of Event2020-02-02
Report Date2020-02-05
Date Reported to FDA2020-02-05
Date Reported to Mfgr2020-03-17
Date Added to Maude2020-03-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
Generic NameCATHETER, CONDUCTION, ANESTHETIC
Product CodeBSO
Date Received2020-03-17
Catalog NumberAK-05503
Lot Number23F19J0388
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer Address3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2020-03-17

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