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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCT KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCT KIT Back to Search Results
Catalog Number AK-05000
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2018
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
Received via medwatch mw5083691.The complaint states: the arrow epidural kit was used on a cse.Placement went easily although there are minimal depth markings on this catheter.Removed catheter at the end of the procedure with slight initial resistance but end that was removed looked like the metal tip of the original catheter.Approximately 2 months later when the patient was having a fluoroscopy guided esi and a foreign body was seen between l2-3 space on fluoroscopy and presumed to be retained epidural catheter.The patient is asymptomatic and recommended to have a follow-up with a neurosurgeon to see if the foreign body needs removal.
 
Event Description
Received via medwatch mw5083691.The complaint states: the arrow epidural kit was used on a cse.Placement went easily although there are minimal depth markings on this catheter.Removed catheter at the end of the procedure with slight initial resistance but end that was removed looked like the metal tip of the original catheter.Approximately 2 months later when the patient was having a fluoroscopy guided esi and a foreign body was seen between l2-3 space on fluoroscopy and presumed to be retained epidural catheter.The patient is asymptomatic and recommended to have a follow-up with a neurosurgeon to see if the foreign body needs removal.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, no record could be found.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 catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu also 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.The device history records were not reviewed as no lot number was provided by the customer and no sales history records could be found.Therefore, the potential cause of the catheter being difficult to remove could not be determined based upon the information provided and without a sample.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCT KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8421171
MDR Text Key138813830
Report Number1036844-2019-00286
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K801912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAK-05000
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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