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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-24703-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the procedure was being performed in the sicu. During insertion, the guide wire kinked. As a result, a new kit was used for the procedure. There was a delay in treatment with no patient harm and no patient death or complications reported.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the guide wire kinked during insertion was confirmed. One 3-lumen 7fr x 30 cm catheter with a guide wire inserted through it, and several other components, were returned. Additionally, the customer provided two photographs showing the returned components inside a plastic bag. The proximal end of the guide wire was unraveled. The distal (j-tip) end of the guide wire was protruding 2. 5 cm beyond the catheter tip and was intact. The guide wire was removed from the catheter. A manual tug test determined that distal weld is intact with the core wire. Kinks were observed in the catheter body located 6 and 20 cm from the proximal weld. Microscopic inspection determined that the core wire was broken adjacent to the proximal weld. The guide wire graphic specifies an outside diameter of. 788/. 826 mm and a length of 683 +/-4 mm. The guide wire length was confirmed to be consistent with the graphic. The outside diameter measured. 804 mm, which met specification. No defects or anomalies were observed on the catheter. A lab inventory. 032" guide wire, with a measured diameter of. 795 mm, was passed through the distal lumen of the catheter without resistance. Other remarks: the instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use. 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. The device history records for the guide wire and catheter were reviewed and did not reveal any manufacturing related issues. 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 7 FR X 30 CM
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 Key5836239
MDR Text Key51522061
Report Number3006425876-2016-00176
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
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 06/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberCS-24703-E
Device Lot Number71F15K1935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2015
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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