MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05401-LMC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998); Hypoesthesia, Arm/Hand (2353); Hypoesthesia, Foot/Leg (2354)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that an epidural catheter was placed in a pt.Initially there were no issues.The pt received a dose of medication with no issues.A second dosing was given (bupivicaine and fentanyl), the pt experienced issues of loss of feeling int eh thoracic region (sensory) and loss of feeling and paralysis in the legs.The pt was evaluated by a neurologist who suggested possible hemi cord lesion due to cord anesthesia from either migration of catheter and injection of medication into the subarachnoid space or direct mechanical injury from the catheter on the cord.Per the report, no imaging was done, so this issue cannot be confirmed and remains subjective.The force of the second bolus is in question as wee as the pt was asymptomatic prior to infusion.The pt was discharged with reduced motor strength in the left leg with some persistent sensory loss along with central cerebellar deficits.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• Brand Name: ARROW SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA 19605
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce pl.
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3815796
• MDR Text Key: 16804472
• Report Number: 1036844-2014-00137
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05401-LMC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1