MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CONTINUOUS PERIPHERAL NERVE BLOCK KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-19608-US1

Device Problems Difficult to Remove (1528); Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When the clinician attempted to remove the catheter there was significant resistance and the patient was experiencing paresthesia.When they were able to remove the catheter it was noted that the polyurethane sheathing pulled up along the catheter and the metal had uncoiled.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The customer reported the catheter was difficult to remove resulting in the catheter to unravel.The customer returned one epidural catheter piece for investigation (reference attached files (b)(4)).The returned catheter piece was visually examined with and without magnification.Visual examination of the returned catheter revealed the likely most proximal end appears to be missing as the extrusion appears to have been cut as the extrusion show no sign of stretching at the point of separation.The extrusion at the distal end of the returned catheter piece shows no signs of stretching.However, the coil wire is stretched well beyond the catheter extrusion tip.The weld end and safety ribbon at the distal tip are still intact (reference files (b)(4)).No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler ((b)(4)).The returned catheter extrusion piece measures approximately 165mm.The inner coils are stretched and extend approximately 154mm beyond the distal tip of the extrusion.The extrusion does not appear to be stretched at the point of separation.At least 430cm of the catheter is missing as the specification for the epidural catheter indicates other remarks: that the proper length of an epidural catheter is 595-603mm per graphic (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.Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation.The ifu for this product, (b)(4), was also reviewed as a part of this complaint investigation.The ifu for this product warns the user, "do not alter the catheter or any other kit/set component during insertion, use, or removal (except as instructed)." the ifu also contains catheter removal instructions with a list of warnings including, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If resistance is encountered, reevaluate position of patient and make another attempt to remove catheter.Clinicians must be aware of the importance of proper removal technique.Since any indwelling catheter can inadvertently be separated if excessive force is applied during removal." a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event.The reported complaint of the catheter being difficult to remove and resulting in catheter unraveling was confirmed based upon the sample received.The returned catheter was missing the proximal end.The extrusion shows no sign of stretching at the point of separation as the catheter appears to have cut.The coils at the distal end stretched well beyond the extrusion.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.The ifu for this product also indicates not to alter the catheter in anyway.Therefore, based upon the condition of the sample received and the observed evidence of the coils stretching at the distal end , operational context caused or contributed to this event.

Event Description

When the clinician attempted to remove the catheter there was significant resistance and the patient was experiencing paresthesia.When they were able to remove the catheter it was noted that the polyurethane sheathing pulled up along the catheter and the metal had uncoiled.The patient's condition was reported as fine.

• Brand Name: CONTINUOUS PERIPHERAL NERVE BLOCK 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: 6133276
• MDR Text Key: 61086368
• Report Number: 1036844-2016-00610
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASK-19608-US1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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