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

Catalog Number CV-25703-E

Device Problems Kinked (1339); Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during insertion/removal of the guide wire in the icu, the guide wire kinked and unwound.As a result, both the guide wire and catheter were removed.A new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint for a kinked and unwound guide wire was confirmed.The customer returned two pictures of the damaged components.The pictures were a chest x-ray and a photo of the guide wire.The x ray showed the device inside the patient and it looks kinked.The picture of the guide wire confirmed the wire was unraveled but no other information could be determined since the photo was not clear and did not contain the entire wire.No further evaluation could be made from the returned pictures.The report was reviewed; however a comprehensive investigation could not be performed because no sample was returned for analysis.The ifu for this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that the use of excessive force during removal could damage or break the wire and cautions not to withdraw the guide wi re against the needle bevel to minimize damaging the guide wire.A device history record review on did not reveal any manufacturing related issues.The probable cause of the guide wire and catheter resistance that resulted in an unraveled guide wire could not be determined based upon the information provided and without a sample.No further actions.

• Brand Name: CVC SET: 3-LUMEN 7FR X 20CM
• 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: 5698847
• MDR Text Key: 46566456
• Report Number: 3006425876-2016-00158
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F15D0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• 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