MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT; ANESTHESIA CONDUCTION KIT

Catalog Number EC-05000

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that while performing a lumbar epidural with ec-05000 and 17g tuohy needle, the catheter sheared off during repositioning.Additional information: during removal the catheter met resistance as it was being withdrawn.The catheter became uncoiled and remained entrapped.The patient required surgical removal.The catheter was removed under microscopic dissection by the neurosurgeon.It was found to be kinked in the ligamentum flavum.The tip was intact with a slight kink however the more proximal portion was uncoiled.The patient is doing very well and did not have any complications.

Event Description

It was reported that while performing a lumbar epidural with ec-05000 and 17g touhy needle, the catheter sheared off during repositioning.Additional information: during removal the catheter met resistance as it was being withdrawn.The catheter became uncoiled and remained entrapped.The patient required surgical removal.The catheter was removed under microscopic dissection by the neurosurgeon.It was found to be kinked in the ligamentum flavum.The tip was intact with a slight kink however the more proximal portion was uncoiled.The patient is doing very well and did not have any complications.

Manufacturer Narrative

Qn#(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, c-05000-135a; rev.02, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm.Advancing catheter more than 5 cm increases likelihood of catheter tip being placed into anterolateral portion of epidural space and increases potential for catheter knotting." the ifu also warns the user, "never tug or quickly pull on catheter during removal from patient to minimize the risk of catheter breakage.If excess resistance is encountered, stop, remove both needle and catheter as a unit, and attempt new puncture.During catheter removal, if resistance is encountered or if catheter stretches excessively, stop, reposition patient to open vertebral interspaces (the force required to remove an epidural catheter can vary depending on patient positioning1), and re-attempt removal.Under no circumstance should extreme force be applied to the catheter during removal." the ifu also cautions the user "to minimize the risk of shearing catheter, never withdraw catheter back against needle bevel." a corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter shearing could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8460403
• MDR Text Key: 140179974
• Report Number: 1036844-2019-00267
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC-05000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention