MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-27702-E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed in the medical ward. When the physician was inserting the guide wire, resistance was met which resulted in the wire kinking. As a result, everything was removed and a new kit was used for the procedure. There was a delay in treatment with no patient harm and no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4). Device evaluation: the report that the guide wire kinked during use was confirmed. One 2-lumen 7fr x 20 cm catheter with a guide wire inserted through it, was returned. A dilator, tray and lidstock were also returned. Additionally, the customer provided three photographs showing the returned components inside a plastic bag. The guide wire / catheter assembly was kinked 1. 5 and 17 cm below the catheter juncture hub. The guide wire was protruding 2 cm from the proximal end and 24 cm from the distal end of the catheter. The guide wire was removed from the catheter. A manual tug test determined that both welds are intact with the core wire. Kinks were observed in the guide wire body located 28 and 43 cm from the j-tip weld. The kinks correspond with those observed in the guide wire / catheter assembly. The guide wire graphic specifies an outside diameter of. 788/. 826 mm and a length of 600 +/-4 mm. The guide wire length was confirmed to be consistent with the graphic. The outside diameter measured. 813 mm, which met specification. After removal of the guide wire, the catheter remained kinked 1. 5 cm below the juncture hub. A lab inventory. 032" guide wire, other remarks: with a measured diameter of. 804 mm, was passed through the catheter without resistance. The instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use. The device history records were reviewed and did not reveal any manufacturing related issues. No manufacturing defects were found during this investigation. Based on the observed damage and information provided, operational context caused or contributed to the event. No further action will be taken.

• Brand Name: CVC SET: 2-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 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: 5836234
• MDR Text Key: 50819601
• Report Number: 3006425876-2016-00175
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• 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: 06/14/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F15K1182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial