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

(b)(4).

Event Description

It was reported that during removal of the guide wire from the female patient's jugularis interna, the guide wire unraveled.As a result, a new kit was opened and used; however, the same issue occurred.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

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 # 3006425876-2016-00217.Device evaluation: the reported complaint of the guide wire broke upon removal was confirmed.The customer returned one guide wire.Visual examination revealed the guide wire is unraveled from the distal end and no kinks were observed.Microscopic examination revealed a discoloration and necking of the core wire in the area of the break.Discoloration at the broken end of the core wire is consistent with proximity to a weld.Further microscopic examination revealed that the distal weld was separated and missing from the end of the coil wire and that the proximal weld was full and spherical.A manual tug test confirmed that the proximal weld remains intact.The broken core wire measured 685mm in length, which is within the specification of 679 mm - 687 mm per guide wire drawing, indicating that no pieces of the core wire are missing.The diameter of the guide wire measured 0.864 mm, which is within the specification of 0.838mm - 0.877 mm per guide wire drawing.Other remarks: the instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions state 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 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 with no findings relevant to this complaint.No manufacturing defects were found during this investigation.A risk evaluation was completed for this complaint.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: 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: 5798749
• MDR Text Key: 49687190
• Report Number: 3006425876-2016-00216
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• 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
• Patient Sequence Number: 1
• Patient Age: 49 YR