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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 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-25703-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion in the sicu, resistance was met when inserting the guide wire. As a result, the doctor pulled back the guide wire and at that time the j-tip of the guide wire was found unraveled. A new kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
(b)(4). Device evaluation: the report that the guide wire was damaged during insertion was confirmed. One guide wire / advancer assembly was returned. The customer also provided a photograph showing the j-tip of a wire guide with a kink / offset coil. The returned guide wire was kinked 2. 5 cm from the distal (j-end) weld. Microscopic examination determined that there was also an offset coil located. 5 mm from the j-end weld. Both welds were full and spherical. A manual tug test confirmed that both welds remain intact and the wire feels typical. The guide wire graphic specifies an outside diameter of. 788/. 826 mm and a length of 600 +/- 4 mm. The guide wire length was measured at 601 mm. The outside diameter was measured at. 797 mm, both measurements were within the specifications. The instruction booklet contains insertion instructions and describes suggested techniques to minimize the likelihood of guide wire damage during use. A device history record review was performed and did not reveal any manufacturing related issues. Since the guide wire is always inserted through another component such as an introducer needle, ars syringe or introducer catheter and none of these components were returned, the probable cause of this issue could not be determined. No further action will be taken.
 
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Brand NameCVC SET: 3-LUMEN 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 Key5670443
MDR Text Key45648022
Report Number1036844-2016-00274
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 05/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberCS-25703-E
Device Lot Number23F15F1365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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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