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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-21242-X1A
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) this report is for the second in a series of two consecutive product problems with the same patient. The first issue has been reported under mdr # 1036844-2016-00468.
 
Event Description
It was reported a second kit was obtained. The physician inserted the guide wire through the needle. When removing the guide wire it unraveled. He felt the wire became caught on the needle and could not withdraw without removing the wire and needle. As a result, a third kit was obtained and placed successfully. There was no patient death or complications reported.
 
Manufacturer Narrative
(b)(4). Device evaluation: it was reported that the physician inserted the spring wire guide through the needle. When removing the guide wire it unraveled. He felt the wire became caught on the needle and could not withdraw without removing the wire and needle. The issue was confirmed. One guide wire inserted through a dilator was returned. The introducer needle involved in the incident was not returned. The guide wire had several bends in guide wire body and was unraveled starting 1. 5 cm from the j-tip. A manual tug test confirmed that the proximal (straight-end) weld remains intact with the coil/core wires. Microscopic inspection determined that the core wire was separated adjacent to the distal weld. The weld appears full and remains attached to the unbroken coil wire. The guide wire graphic specifies the length at 454 +/- 4 mm and the outside diameter at. 838/. 877 mm. The length of the broken core wire was confirmed to be consistent with the graphic; therefore no pieces appear to be missing. The diameter of the guide wire measured 0. 854 mm, which was within specification. The dilator body was curved and the tip was pushed back. The inside diameter of the dilator tip could not be measured because of the damage. The undamaged proximal end of the guide wire was inserted through the dilator other remarks: without resistance. The instructions for use 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 device history record review was performed and 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 the event. No further action will be taken.
 
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Brand NameMAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO
Type of DeviceARROWG+ARD 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 Key5876860
MDR Text Key53044871
Report Number1036844-2016-00469
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Catalogue NumberCDC-21242-X1A
Device Lot Number23F16D0196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2016
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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