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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH KIT: 19G CATH, 17G X 8CM NDL; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. STIMUCATH KIT: 19G CATH, 17G X 8CM NDL; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AB-19608-K
Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problems Tingling (2171); No Consequences Or Impact To Patient (2199)
Event Date 03/04/2019
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 a flex block catheter was placed on the between c5/c6 nerve root, initial placement felt resistance, seemed to catch on something but could not be retracted.Infusion of the drug felt the spread was fine, so they left the catheter in place.The patient had successful surgery and patient was discharged home.After 48 hours and onq fully discharged aps team contacted the patient to remove the catheter.The patient was unable to pull it out on their own; a doctor was tasked with removing the catheter.He flushed to loosen tissue, used tissue manipulation and still was unable to remove the catheter.At first there was no pain, no complication and catheter did dislodge a little bit.Neurology was called to consult.An x-ray was performed and showed that perhaps a loop was formed in the c5 root.They pulled on it and caused paresthesia that required surgical removal.The catheter tip was found to be bent and flexed a little inside the c5 nerve root/sheath.The patient's condition was reported as fine.
 
Event Description
It was reported that a flex block catheter was placed on the between c5/c6 nerve root, initial placement felt resistance, seemed to catch on something but could not be retracted.Infusion of the drug felt the spread was fine, so they left the catheter in place.The patient had successful surgery and patient was discharged home.After 48 hours and onq fully discharged aps team contacted the patient to remove the catheter.The patient was unable to pull it out on their own; a doctor was tasked with removing the catheter.He flushed to loosen tissue, used tissue manipulation and still was unable to remove the catheter.At first there was no pain, no complication and catheter did dislodge a little bit.Neurology was called to consult.An x-ray was performed and showed that perhaps a loop was formed in the c5 root.They pulled on it and caused paresthesia that required surgical removal.The catheter tip was found to be bent and flexed a little inside the c5 nerve root/sheath.The patient's condition was reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, b-02060-101c; rev 3, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Forcefully pulling back on catheter may result in catheter breakage.Excessive force should never be applied to nerve block catheters.If resistance is encountered, the position of the patient should be re-evaluated and another attempt to remove the catheter should be made.Skin traction in the direction opposite of that applied to catheter may facilitate removal.If removal is difficult, it is recommended that an x-ray be taken and that a consultation with a specialist be considered." 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.
 
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Brand Name
STIMUCATH KIT: 19G CATH, 17G X 8CM NDL
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8497557
MDR Text Key141394456
Report Number1036844-2019-00352
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K122027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue NumberAB-19608-K
Device Lot Number23F18G0412
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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