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

Catalog Number AK-05560

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

An epidural catheter was placed into laboring patient without issues but it was difficult to remove at the end.The internal wire broke or unraveled at approximately the 9cm mark when removal was attempted.The catheter was surgically removed.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, (b)(4); rev.7, 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.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." 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.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.The potential cause of the catheter breaking during removal could not be determined based upon the information provided and without a sample.

Event Description

An epidural catheter was placed into laboring patient without issues but it was difficult to remove at the end.The internal wire broke or unraveled at approximately the 9cm mark when removal was attempted.The catheter was surgically removed.The patient's condition was reported as fine.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6037561
• MDR Text Key: 57797990
• Report Number: 1036844-2016-00523
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AK-05560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention