Received from fda on 6/10/2019 via report # (b)(4).The patient was admitted for a left shoulder arthroscopy.An interscalene peripheral nerve catheter (pnc) was placed by an anesthesia provider for management of post-pain and analgesia using ultrasound guidance to verify placement.The patient did well and was discharged with the pnc catheter and on-q pain pump which provides analgesia/nerve block in an effort to reduce the amount of narcotic analgesia the patient needs to take.The anesthesia pain team calls the patient to assess for any complications and assist with catheter removal.The patient and his wife were directed to remove the catheter three days after implantation, while an anesthesia provider was on the phone assisting.They were unable to remove the catheter and were directed to come to the emergency department for removal.Neither the anesthesia nor orthopedics physicians could remove the catheter.A neurosurgical consult was obtained, and it was decided to schedule the patient for surgical removal.The patient was placed on antibiotics and returned for catheter removal.The patient has recovered well.
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(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 states "trained personnel well versed in anatomical landmarks, safe technique, and potential complications must perform the procedure." the ifu also 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.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 indicate a manufacturing related issue.Therefore, the potential cause of the catheter being difficult to remove could not be determined based upon the information provided and without the sample.
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Received from fda on 6/10/2019 via report #2100090000-2019-8004.The patient was admitted for a left shoulder arthroscopy.An interscalene peripheral nerve catheter (pnc) was placed by an anesthesia provider for management of post-pain and analgesia using ultrasound guidance to verify placement.The patient did well and was discharged with the pnc catheter and on-q pain pump which provides analgesia/nerve block in an effort to reduce the amount of narcotic analgesia the patient needs to take.The anesthesia pain team calls the patient to assess for any complications and assist with catheter removal.The patient and his wife were directed to remove the catheter three days after implantation, while an anesthesia provider was on the phone assisting.They were unable to remove the catheter and were directed to come to the emergency department for removal.Neither the anesthesia nor orthopedics physicians could remove the catheter.A neurosurgical consult was obtained, and it was decided to schedule the patient for surgical removal.The patient was placed on antibiotics and returned for catheter removal.The patient has recovered well.
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