MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-21242-X1A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) this report is for the second in a series of two consecutive product problems with the same patient. The first issue has been reported under mdr # 1036844-2016-00468.

Event Description

It was reported a second kit was obtained. The physician inserted the guide wire through the needle. When removing the guide wire it unraveled. He felt the wire became caught on the needle and could not withdraw without removing the wire and needle. As a result, a third kit was obtained and placed successfully. There was no patient death or complications reported.

Manufacturer Narrative

(b)(4). Device evaluation: it was reported that the physician inserted the spring wire guide through the needle. When removing the guide wire it unraveled. He felt the wire became caught on the needle and could not withdraw without removing the wire and needle. The issue was confirmed. One guide wire inserted through a dilator was returned. The introducer needle involved in the incident was not returned. The guide wire had several bends in guide wire body and was unraveled starting 1. 5 cm from the j-tip. A manual tug test confirmed that the proximal (straight-end) weld remains intact with the coil/core wires. Microscopic inspection determined that the core wire was separated adjacent to the distal weld. The weld appears full and remains attached to the unbroken coil wire. The guide wire graphic specifies the length at 454 +/- 4 mm and the outside diameter at. 838/. 877 mm. The length of the broken core wire was confirmed to be consistent with the graphic; therefore no pieces appear to be missing. The diameter of the guide wire measured 0. 854 mm, which was within specification. The dilator body was curved and the tip was pushed back. The inside diameter of the dilator tip could not be measured because of the damage. The undamaged proximal end of the guide wire was inserted through the dilator other remarks: without resistance. 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 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 the event. No further action will be taken.

• Brand Name: MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO
• 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: 5876860
• MDR Text Key: 53044871
• Report Number: 1036844-2016-00469
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2018
• Device Catalogue Number: CDC-21242-X1A
• Device Lot Number: 23F16D0196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial