MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 12 FR X 20 CM ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CS-15123-F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4). This report is for the first in a series of two consecutive product problems with the same patient. The second issue has been reported under mdr # 3006425876-2016-00216.

Event Description

It was reported that during removal of the second guide wire from the female patient's jugularis interna, the guide wire again unraveled. As a result, a third kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence. The patient involved was a (b)(6) female with a height of (b)(6).

Manufacturer Narrative

(b)(4). Device evaluation: the reported complaint of the guide wire unraveled upon removal was confirmed. The customer returned one guide wire. Visual examination revealed the guide wire is unraveled from the distal weld and five kinks were observed throughout the middle of the wire. Microscopic examination revealed that the core wire broke adjacent to the distal weld and exhibited necking and had a jagged edge. Microscopic examination revealed that the distal weld was attached to the end of the coil wire and that both welds were full and spherical. A manual tug test confirmed that the proximal weld remains intact. The broken core wire measured 683mm in length, which is within the specification of 679 mm - 687 mm per guide wire drawing, indicating that no pieces of the wire are missing. The outside diameter (od) of the guide wire measured 0. 822 mm, which is not within the od specification of the wire in this kit; 0. 838mm - 0. 877 mm per guide wire drawing. The returned wire is a 0. 032" wire and the guide wire in this kit is a 0. 035" wire. The origin of this wire was not reported. The instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use. The instructions state that if resistance. Other remarks: 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 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 were reviewed and did not reveal any manufacturing related issues. A risk evaluation was completed for this complaint. Since the returned wire does not match the reported kit, the cause of this complaint could not be determined. No further action will be taken.

• Brand Name: CVC SET: 3-LUMEN 12 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 CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5798794
• MDR Text Key: 49687089
• Report Number: 3006425876-2016-00217
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/04/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F16D0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial