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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM ADULT MULTI LUMEN CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM ADULT MULTI LUMEN CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-45703-1A
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that three physicians have complained over the past 3-4 weeks that they have been having issues with the guide wire. The md said that he advanced the guide wire through the introducer needle without an issue. As he advanced the wire through the vessel it would stick then not advance or withdraw. He said he knew he was in the vessel. It has happened to two other physicians. The rep. Discussed the insertion angle of the needle and dilator and stated that he's a very experienced inserter as the others. One physician had the spring-wire unravel as they were attempting to get the wire out of the patient. There was no reported delay, death, or complications to the patient as a result of this occurrence.
 
Manufacturer Narrative
(b)(4). Device evaluation: the report that the guide wire unraveled was confirmed. Returned were a guide wire, an ars with a blue tip, an introducer needle, and a dilator. The tip of the dilator was undamaged. The cannula of the needle was bent 5 cm from the tip of the needle. The guide wire was kinked and bent along half its length. The core wire was separated adjacent to the weld at the proximal end. Discoloration was observed at the broken end of the core wire, which is consistent with proximity to a weld. Microscopic inspection revealed a plastic deformation and necking of the wire in the area of the break. The proximal weld appears full and remains attached to the unbroken coil wire. A manual tug test confirmed that the distal weld is intact. The core wire measured approximately 60 cm in length. Based upon the measured length of the broken core wire, no pieces appear to be missing. The od of the guide wire measured 0. 790 mm. This met specification of 0. 788 - 0. 826 mm per guide wire graphic. A 0. 032 inch od lab guide wire was inserted into the ars and introducer needle four times with the plunger in and then out, rotating the sample 1/4 turn each time. Blood residue came out of the needle during the test; however, no resistance was experienced passing the guide wire through the ars other remarks: and needle. The instruction booklet provided with the kit 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 review of the device history records did not reveal any manufacturing related issues. The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking. Guide wire breakage may occur if a force greater than the design specification is applied during removal. Based on these circumstances, operational context caused or contributed to this event. No further action will be taken.
 
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Brand Name3-L CVC KIT: 7 FR X 20 CM
Type of DeviceADULT MULTI LUMEN CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5852656
MDR Text Key51343468
Report Number1036844-2016-00453
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberCDC-45703-1A
Device Lot Number23F15M0880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2015
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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