MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; ARROWG+ARD CATHETER PRODUCTS

Catalog Number ASK-45703-PHF2

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when removing the guide wire from the catheter, the guide wire unraveled.The guide wire was removed in its entirety, however, the catheter was able to remain in place.It was not known if this caused a delay, however, there was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the report that the guide wire unraveled was confirmed.Returned was one guide wire.The catheter was not returned.The guide wire was kinked 39 cm from the distal tip.The core wire was separated adjacent to the weld at the distal 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 distal weld appears full and remains attached to the unbroken coil wire.A manual tug test confirmed that the proximal weld is intact.The core wire measured approximately 60.4 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.The instruction booklet provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove other remarks: the guide wire.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.The device history records for the guide wire were reviewed with no relevant findings.The investigation found no evidence to suggest a manufacturing related cause.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: MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• 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: 5848435
• MDR Text Key: 51242389
• Report Number: 1036844-2016-00450
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: ASK-45703-PHF2
• Device Lot Number: 23F16C0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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