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

Catalog Number AM-05500

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (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 the catheter could not be extracted from the patient.After trying to remove the catheter slowly, the catheter was cut.

Event Description

It was reported that the catheter could not be extracted from the patient.After trying to remove the catheter slowly, the catheter was cut.

Manufacturer Narrative

(b)(4).The customer reported the catheter was difficult to remove.The customer returned one piece of an epidural catheter for investigation.The returned catheter piece was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the distal end of the catheter was returned based on the marking at the end of the catheter.The likely most proximal end appears to have been cut.The catheter appears used as biological material can be seen between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler (ga-ln-0560-003).The returned catheter extrusion measures approximately 53mm.This indicates at least 83.2cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5 cm per graphic kz-05400-002 rev.9.Specifications per graphic kz-05400-002 rev.9 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance the catheter more than 5 cm beyond the needle tip.Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting." the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.A corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of epidural catheter being difficult to remove was confirmed based upon the sample received.The returned catheter piece was missing approximately 83.2cm of extrusion from the likely most proximal end of the catheter.The returned catheter appears to have been cut.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, unintentional user error caused or contributed to this event.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-109a; rev.06, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance the catheter more than 5 cm beyond the needle tip.Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting." the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.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 on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter being difficult to remove could not be determined based upon the information provided and without a sample.

Event Description

It was reported that the catheter could not be extracted from the patient.After trying to remove the catheter slowly, the catheter was cut.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8134691
• MDR Text Key: 129478407
• Report Number: 1036844-2018-00307
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: AM-05500
• Device Lot Number: 13F18D0399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/10/2019; 02/14/2019
• Supplement Dates FDA Received: 01/16/2019; 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1