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 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).No sample will be returned for evaluation.

Event Description

It was alleged that during insertion, resistance was met when inserting the guide wire resulting in the kinking of the wire.As a result, a new kit was opened and used without issue.There is no additional information to follow.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the guide wire kinked during insertion was confirmed.Returned by the customer was one guide wire with additional components that included the arrow raulerson syringe/introducer needle assembly.A visual examination of the guide wire revealed a partially opened j-tip.A manual tug test confirmed that both welds remain intact.The guide wire measured 602 mm in length and the outside diameter (od) measured.800 mm.The returned guide wire was within specification for length and od per guide wire graphic (length: 596 - 604 mm and od: 0.788- 0.826 mm).Microscopic examination of the guide wire revealed kinks at 2.8, 46.1 and 59.4 cm from the distal tip.Visual inspection of the ars/needle assembly was performed and both appeared typical but used.A functional test was performed in an attempt to verify the complaint using the returned guide wire and the ars and needle.The guide wire was inserted into the ars and needle four times each at a different orientation by rotating the syringe 1/4 turns at each insertion and with the plunger in and out.The guide wire passed through each time and no resistance was met.The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use.A device history records other remarks: review was performed 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: 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: 5701079
• MDR Text Key: 46633055
• Report Number: 3006425876-2016-00164
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 07/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• 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
• Patient Sequence Number: 1