MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 30 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-24703-E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed in the sicu.During insertion, the guide wire kinked.As a result, 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 insertion was confirmed.One 3-lumen 7fr x 30 cm catheter with a guide wire inserted through it, and several other components, were returned.Additionally, the customer provided two photographs showing the returned components inside a plastic bag.The proximal end of the guide wire was unraveled.The distal (j-tip) end of the guide wire was protruding 2.5 cm beyond the catheter tip and was intact.The guide wire was removed from the catheter.A manual tug test determined that distal weld is intact with the core wire.Kinks were observed in the catheter body located 6 and 20 cm from the proximal weld.Microscopic inspection determined that the core wire was broken adjacent to the proximal weld.The guide wire graphic specifies an outside diameter of.788/.826 mm and a length of 683 +/-4 mm.The guide wire length was confirmed to be consistent with the graphic.The outside diameter measured.804 mm, which met specification.No defects or anomalies were observed on the catheter.A lab inventory.032" guide wire, with a measured diameter of.795 mm, was passed through the distal lumen of the catheter without resistance.Other remarks: the instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use.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.The device history records for the guide wire and catheter were reviewed and did not reveal any manufacturing related issues.Based on these circumstances, operational context caused or contributed to the event.No further action will be taken.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 30 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: 5836239
• MDR Text Key: 51522061
• Report Number: 3006425876-2016-00176
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

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: 08/31/2017
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F15K1935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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