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

Catalog Number EC-05500

Device Problem Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

It was reported that the catheter was removed from the spinal area while attempting to disconnect the tubing from the snaplock; the catheter uncoiled.An x-ray was performed and no device parts were seen in the patient.The report indicates that there was no patient injury.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter the coils unraveled when the catheter was being removed from the patient.The customer returned one snaplock adapter and one epidural catheter for investigation.The components were received connected together.The customer also returned one sealed kit with the same kit & lot # as the reported complaint (reference attached files (b)(4)).The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed catheter appears used.The distal end shows signs of stretching and coil wire appears to be stretched and the extrusion is damaged, but the distal tip is intact.The coil wire is stretched well beyond the catheter extrusion tip.The proximal side of the catheter appears to be intact as no damage was observed.No other defects or anomalies were observed (reference files (b)(4)).A dimensional inspection was performed on the other remarks: returned catheter piece using a ruler (c05158).The returned catheter extrusion measures approximately 93.5cm.The inner coils are stretched and extend approximately 12cm beyond the tip of the extrusion.The extrusion appears to be stretched at the distal end of the catheter.This is why the catheter is slightly outside of specification of 88.5-91.5 cm per graphic kz-05400-002 rev.08.No part of the catheter appears to be missing.Specifications per graphic kz-05400-002 rev.8 were reviewed as a part of this complaint investigation.The ifu for this product, c-05500-108a; rev.2, was also reviewed as a part of this complaint investigation.The ifu contains catheter removal instructions with a list of warnings including, "never tug or quickly pull on catheter during removal from patient to reduce risk of breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." the ifu also provides alternate catheter removal techniques if difficulty is encountered and indicates "since any epidural catheter can inadvertently be separated if excessive force is applied during removal, clinicians must be aware of the importance of proper removal technique." a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event.The reported complaint of the coils unraveled when the catheter was being removed from the patient was confirmed based upon the sample received.The distal end of the returned catheter was intact, however, there were signs of stretching and the coil wire was stretched well beyond the extrusion.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore, based upon the condition of the sample received and the observed evidence of stretching at the distal end, operational context caused or contributed to this event.

Event Description

It was reported that the catheter was removed from the spinal area while attempting to disconnect the tubing from the snaplock; the catheter uncoiled.An x-ray was performed and no device parts were seen in the patient.The report indicates that there was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6036801
• MDR Text Key: 57731400
• Report Number: 3006425876-2016-00313
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: EC-05500
• Device Lot Number: 71F15M0445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1