• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 07/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion in the ar, resistance was met when inserting the guide wire. As a result, the guide wire was removed and found kinked. 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 reported complaint of the guide wire became kinked during insertion was confirmed. The customer returned one guide wire. Visual examination of the guide wire revealed five kinks at the distal end of the wire and the j- bend appeared opened. The five kinks were measured at 7 mm, 1. 3, 1. 6, 2. 5 and 2. 8 cm from the distal weld. Microscopic examination confirmed the five kinks and found that all five kinks had offset coils. Microscopic examination also confirmed that both welds were full and spherical. A manual tug test confirmed that both welds remain intact. The guide wire measured approximately 602mm in the total length and exhibited an outside diameter (od) measured 0. 804 mm. The returned guide wire was within specification for length and od per guide wire graphic (length: 596 - 604 mm and od: 0. 788- 0. 826mm). The instructions for use, describe suggested techniques to minimize the likelihood of guide wire damage during use. The device history record review was performed 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 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 Key5772419
MDR Text Key48866455
Report Number3006425876-2016-00196
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 07/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberCS-25703-E
Device Lot Number71F15J1990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2016
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 Manufactured09/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-