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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-25703
Device Problems Kinked (1339); Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer returned one spring wire guide (swg) guide wire for evaluation. The catheter was not returned. The swg wire was unraveled and showed evidence of use. Visual examination revealed the swg is unraveled from the proximal weld and has multiple kinks in the guide wire body. The distal j-bend is undamaged. Microscopic examination of the swg confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire. The exposed proximal core wire tip is rounded at the point of separation. Both welds appeared full and spherical. The broken core wire measured 600 mm in length, which met specification; therefore, no pieces of the core wire appear to be missing. The swg outer diameter was measured and was found to be within specification. A manual tug test confirmed that the distal weld was intact. A device history record (dhr) review was performed on the guide wire and the catheter and no relevant manufacturing issues were identified. The instructions-for-use provided with this 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 2-3 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 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 proximal weld. Dimensional inspection and a dhr 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 11070:1999 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, it was determined that operational context likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports that upon removing the guide there was an obstruction and the guide was deformed when removed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that upon removing the guide there was an obstruction and the guide was deformed when removed.
 
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Brand NameARROW CVC SET: 3-LUMEN 7FR X 20CM
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 Key6911916
MDR Text Key249720066
Report Number3006425876-2017-00419
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
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 09/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberCV-25703
Device Lot Number71F17D1693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2017
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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