• 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. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP

  • 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. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-25802-E
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). "the swg unraveled after withdrawing from introducer needle. The customer returned a used unraveled spring wire guide (swg). The introducer needle was not returned. Visual examination of the swg revealed the guide wire is unraveled from the distal weld. The distal end of the core wire protruding was flat and retained its j shape. The guide wire body also has multiple bends in the inner core wire and stretched coils. Microscopic examination of the swg confirmed the inner core wire fractured off adjacent to the distal weld. The distal weld was present at the end of the unraveled coil wire and the proximal weld was still intact. Both the proximal and distal welds appeared full and spherical. The broken core wire measured 603mm in length, which met specification; therefore no pieces appear to be missing. The outside diameter (od) of the guide wire measured 0. 794mm, which met specification. A manual tug test confirmed that the distal weld was intact. A device history record review was performed and no relevant findings were identified. The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use. It states 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 2-3cm 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 report that the guide wire was unraveled was confirmed through examination of the returned sample. The guide wire core wire was broken adjacent to the distal weld. Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue. Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2. 75 pounds force. This internal specification is higher than the bs en iso 11070:2014 standard of 2. 2 pounds force for this size wire. 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 likely contributed to this event, however, the probable cause of guide wire and introducer needle resistance could not be determined based upon the information provided and without the introducer needle being returned. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer alleges resistance was met when inserting the swg (spring wire guide) through the ars (syringe). The swg unraveled after withdrawing from introducer needle.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges resistance was met when inserting the swg (spring wire guide) through the ars (syringe). The swg unraveled after withdrawing with catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW CVC SET: 2-LUMEN 8 FR X 20 CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7237212
MDR Text Key264507774
Report Number3006425876-2018-00071
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 distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberCS-25802-E
Device Lot Number23F17F0591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-