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

Catalog Number CS-25703-E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in icu, resistance was met resulting in the guide wire kinking.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

(b)(4).Device evaluation: the report that the guide wire kinked during insertion was confirmed.Returned was a guide wire.No other components were returned.The customer also provided a photo of the sample.The guide wire exhibited signs of use.It was kinked approximately 1 cm from the bottom of the j-bend.It was also kinked at 12.5 and 14 cm from the proximal end.A manual tug test confirmed that both welds were intact.The guide wire measured 60.2 cm in length, which was consistent with the guide wire graphic.The od of the guide wire measured 0.799mm.This met specification of 0.788 - 0.826mm per guide wire graphic.The guide wire is used with other components during insertion; however, the customer did not provide any details about the procedure and only returned the guide wire.The instruction booklet describes suggested techniques to minimize the likelihood of guide wire damage during use.A review of the device history records did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component during the procedure and no other components were returned, the probable cause of this issue could not be determined.No further action will be taken.

• Brand Name: CVC SET: 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 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: 5735543
• MDR Text Key: 47746483
• Report Number: 3006425876-2016-00187
• 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

• Date FDA Received: 06/20/2016
• 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-25703-E
• Device Lot Number: 71F15K0992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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