MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 3-LUMEN 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number AK-45703-ACDC

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in the or during insertion in the female patient's subclavia, resistance was met between the guide wire and the needle.The user tried to remove the guide wire and the wire unraveled.As a result, both the needle and guide wire where then together removed without issue.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 reported complaint that resistance was met between the guide wire and the needle and upon removal of the guide wire it untraveled was confirmed.The customer returned one guide wire.The introducer needle was not returned.Visual examination revealed multiple kinks throughout the wire and that the wire is unraveled from the proximal end.The proximal weld was observed at the end of the coil wire and the coil wire is unraveled.Microscopic examination revealed that both welds are full and spherical and the broken end of the core wire exhibited necking.The manual tug test revealed that the distal weld is intact.The core wire measured 598 mm, which is within the specification of 596 mm - 604mm per the guide wire graphic and indicates that no pieces are missing.The outside diameter of the guide wire measured 0.804 mm, which also meets the outside diameter specification of 0.788 - 0.826 mm per the guide wire graphic.The ifu for this product cautions that if resistance is encountered while advancing or withdrawing the guide wire do not use force and warns not to retract the guide wire against the edge of needle while in a vessel to minimize guide wire damage.A device history record review was performed with no relevant findings.Other remarks: 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 the event.No further action will be taken.

• Brand Name: CVC KIT: 3-LUMEN 7 FR X 20 CM
• 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: 6171389
• MDR Text Key: 62335286
• Report Number: 1036844-2016-00670
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: AK-45703-ACDC
• Device Lot Number: 23F16E0770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• 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