ARROW INTERNATIONAL INC. STIMUCATH KIT: 19G CATH, 17G X 8CM NDL; ANESTHESIA CONDUCTION KIT
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Catalog Number AB-19608-K |
Device Problems
Entrapment of Device (1212); Material Twisted/Bent (2981)
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Patient Problems
Tingling (2171); No Consequences Or Impact To Patient (2199)
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Event Date 03/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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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