MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CDC-45703-1A

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that three physicians have complained over the past 3-4 weeks that they have been having issues with the guide wire.The md said that he advanced the guide wire through the introducer needle without an issue.As he advanced the wire through the vessel it would stick then not advance or withdraw.He said he knew he was in the vessel.It has happened to two other physicians.The rep.Discussed the insertion angle of the needle and dilator and stated that he's a very experienced inserter as the others.One physician had the spring-wire unravel as they were attempting to get the wire out of the patient.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the guide wire unraveled was confirmed.Returned were a guide wire, an ars with a blue tip, an introducer needle, and a dilator.The tip of the dilator was undamaged.The cannula of the needle was bent 5 cm from the tip of the needle.The guide wire was kinked and bent along half its length.The core wire was separated adjacent to the weld at the proximal end.Discoloration was observed at the broken end of the core wire, which is consistent with proximity to a weld.Microscopic inspection revealed a plastic deformation and necking of the wire in the area of the break.The proximal weld appears full and remains attached to the unbroken coil wire.A manual tug test confirmed that the distal weld is intact.The core wire measured approximately 60 cm in length.Based upon the measured length of the broken core wire, no pieces appear to be missing.The od of the guide wire measured 0.790 mm.This met specification of 0.788 - 0.826 mm per guide wire graphic.A 0.032 inch od lab guide wire was inserted into the ars and introducer needle four times with the plunger in and then out, rotating the sample 1/4 turn each time.Blood residue came out of the needle during the test; however, no resistance was experienced passing the guide wire through the ars other remarks: and needle.The instruction booklet provided with the kit 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 review of the device history records did not reveal any manufacturing related issues.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: 3-L CVC KIT: 7 FR X 20 CM
• Type of Device: ADULT MULTI LUMEN 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: 5852656
• MDR Text Key: 51343468
• Report Number: 1036844-2016-00453
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: CDC-45703-1A
• Device Lot Number: 23F15M0880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2015
• 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