MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-XP1A

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the clinician experienced difficulty when placing a subclavian line.The guide wire bends/kinks and it becomes difficult to thread the catheter over the guide wire.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: it was reported that it was then difficult to thread the catheter over the wire was confirmed.The customer returned a guide wire and three pictures.No catheter was returned.The pictures showed the lidstock and part of guide wire with one kink visible.Visual examination of the returned sample revealed one kink in the middle of the wire and the j- bend was partly opened.A manual tug test confirmed both welds are intact.Microscopic examination confirmed the kink and confirmed that both welds were full and spherical.No separations or offset coils were observed.The kink was measured at 26.3 cm from the distal weld.The guide wire measured 60.1 cm, which meets the length specifications of 59.6 - 60.4 cm per the guide wire graphic.The diameter (od) of the guide wire measured 0.803 mm, which is also within the od specification of 0.788 - 0.826 mm per the guide wire graphic.The instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.A device history record review was performed and found no evidence to indicate other remarks: a manufacturing related cause.The probable cause of the guide wire kinking with catheter resistance during insertion could not be determined based upon the information provided and without a complete sample.No further action will be taken.

• Brand Name: PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6143830
• MDR Text Key: 61402433
• Report Number: 1036844-2016-00659
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15M0587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1