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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7FR X 20CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
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.
 
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Brand NameCVC SET: 3-LUMEN 7FR X 20CM
Type of DeviceARROWG+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 Key5698847
MDR Text Key46566456
Report Number3006425876-2016-00158
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeEC
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberCV-25703-E
Device Lot Number71F15D0072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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