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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 ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-45703-A1A
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the physician experienced difficulty during insertion. He attempted to remove the wire once it was threaded over the catheter. At which time, the spring wire guide unraveled and the catheter and wire were removed as one. Another kit was used and placed successfully. There was no patient death or complications reported.
 
Manufacturer Narrative
(b)(4) device evaluation: the report that the guide wire unraveled during use was confirmed. One 3-l 7 fr x 20 cm catheter with an unraveled guide wire inserted through it was returned. Visual examination revealed a 2mm section of the guide wire was protruding from the catheter tip. An unraveled section of the guide wire was protruding from the proximal end of the distal luer hub. Microscopic examination determined that the core wire is broken adjacent to the distal weld. A manual tug test confirmed that the proximal weld remains intact. The guide wire drawing specifies a length of 600 +/- 4 mm and a diameter of. 788/. 826 mm. The broken core wire was confirmed to be consistent with the guide wire graphic; therefore, no pieces appear to be missing. The diameter of the guide wire measured 0. 797 mm. The catheter showed evidence of use but no defects or anomalies were observed. A. 035" gage wire was passed through the distal lumen which meets the requirements of the catheter graphic. Instructions for use describes suggested techniques to mini mize the likelihood of guide wire damage during use. The instructions caution that withdrawing the guide wire against other remarks: 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 Name3-L CVC KIT: 7 FR X 20 CM
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 Key5551141
MDR Text Key41986486
Report Number1036844-2016-00202
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 04/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberCDC-45703-A1A
Device Lot Number23F15F1240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2015
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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