MAUDE Adverse Event Report: ARROW INTERNATIONAL FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT

Model Number MM-05503

Device Problems Coiled (1098); Knotted (1340); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/29/2017

Event Type  Injury  

Event Description

Lumbar epidural analgesia for labor performed with 19 gauge x 90cm flextip plus without complication.After delivery, 2 attempts to remove catheter were unsuccessful due to knotted catheter.Pt remained asymptomatic, neurologically intact.Neurosurgery service contacted, recommended ct scan without contrast l/spine.Ct performed on (b)(6) 2017 showed a thin catheter extending from dorsal left paramedial subcutaneous soft tissue, entering epidural space at l4-l5 level.Catheter appeared coiled on itself within the dorsal aspect of spinal canal.On (b)(6) 2017 in the operating room, pt underwent lumbar removal of catheter from l4-l5 epidural space.A knot was noted which was preventing catheter from being removed prior to surgery.The catheter was removed in its entirety and sent to pathology.There were no sequelae and pt discharged home on (b)(6) 2017.Dates of use: (b)(6) 2017.Diagnosis or reason for use: labor analgesia."is the product compounded: no.".

• Brand Name: FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL
• MDR Report Key: 6883301
• MDR Text Key: 87189129
• Report Number: MW5072259
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: MM-05503
• Device Lot Number: 23F17F0460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 66