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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 12 FR X 20 CM ADULT MULTI LUMEN CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 12 FR X 20 CM ADULT MULTI LUMEN CATHETER PRODUCTS Back to Search Results
Catalog Number CS-15123-F
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during removal of the guide wire from the female patient's jugularis interna, the guide wire unraveled. As a result, a new kit was opened and used; however, the same issue occurred. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence. The patient involved was a (b)(6) female with a height of (b)(6).
 
Manufacturer Narrative
Qn#(b)(4). This report is for the first in a series of two consecutive product problems with the same patient. The second issue has been reported under mdr # 3006425876-2016-00217. Device evaluation: the reported complaint of the guide wire broke upon removal was confirmed. The customer returned one guide wire. Visual examination revealed the guide wire is unraveled from the distal end and no kinks were observed. Microscopic examination revealed a discoloration and necking of the core wire in the area of the break. Discoloration at the broken end of the core wire is consistent with proximity to a weld. Further microscopic examination revealed that the distal weld was separated and missing from the end of the coil wire and that the proximal weld was full and spherical. A manual tug test confirmed that the proximal weld remains intact. The broken core wire measured 685mm in length, which is within the specification of 679 mm - 687 mm per guide wire drawing, indicating that no pieces of the core wire are missing. The diameter of the guide wire measured 0. 864 mm, which is within the specification of 0. 838mm - 0. 877 mm per guide wire drawing. Other remarks: the instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use. The instructions state that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel. In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire. 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. The device history records were reviewed with no findings relevant to this complaint. No manufacturing defects were found during this investigation. A risk evaluation was completed for this complaint. 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 NameCVC SET: 3-LUMEN 12 FR X 20 CM
Type of DeviceADULT MULTI LUMEN 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 Key5798749
MDR Text Key49687190
Report Number3006425876-2016-00216
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K970864
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 07/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue NumberCS-15123-F
Device Lot Number71F16D0251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2016
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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