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 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that during insertion in cvsu, the user was unable to pass the guide wire through the arrow raulerson syringe smoothly.As a result, a new 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.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the customer reported that during insertion the user was unable to pass the guide wire through the ars smoothly could not be confirmed.The customer returned one guide wire, and one ars.The introducer needle was not returned.The customer also returned a picture of the affected components in an opened kit.No additional information could be obtained from the photo.The guide wire had one kink near the distal end and the ars appeared typical and the plunger moved freely.Microscopic examination of the guide wire revealed that both welds were observed to be full and spherical and no separations were observed.A tug on the wire at both ends confirmed the welds were intact.The guide wire length measured 602 mm and the od measured 0.798 mm.The od is within specification but the length is not per guide wire graphic (length: 687- 679 mm; od: 0.788-0.826mm) indicating that the guide wire returned is not the configuration of guide wire that is packaged in this kit.Microscopic examination of the ars revealed that no damage or defects was observed.A functional test was performed in an attempt to verify the complaint using the returned guide wire and ars.The guide wire was inserted into the ars four times each at a other remarks: different orientation by rotating the syringe 1/4 turns at each insertion and with the plunger in and out.The guide wire passed th rough each time and met resistance at the location where the kink is located.However, no resistance was met on the wire after the kink had passed through the luer slip tip of the syringe.The test was repeated using a lab inventory 0.038 in wire gauge.No resistance was met.The test was repeated for a third time using the straight end of the guide wire.No resistance was met indicating that there are no functional issues with the ars syringe.The ifu for this product describes suggested techniques to minimize the likelihood of guide wire damage during use.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.A device history record review was performed and found no evidence to suggest a manufacturing related cause.The probable cause of guide wire resistance during insertion into the ars could not be determined based upon the information provided and without a complete sample.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: 5735318
• MDR Text Key: 47743963
• Report Number: 3006425876-2016-00183
• 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: 06/17/2016

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: 06/17/2016
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• 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