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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number SI-11142
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Medical doctor was performing the procedure according to ifu. During the insertion, md could not advance the swg due to the folded guide wire. Since then, medical doctor had to use new product. The procedure has been completed without any abnormality.
 
Event Description
The customer reports: md was performing the procedure according to ifu. During the insertion, md could not advance the swg due to the folded guide wire. Since then, md had to use new product. The procedure has been completed without any abnormality.
 
Manufacturer Narrative
(b)(4). The customer returned a mac kit and lidstock with a single spring wire guide (swg) assembly for evaluation. The guide wire was returned within the advancer tube and showed signs of use. The guide wire was observed to have a slight bend at the distal end right below the j-bend. Microscopic examination confirmed the bend in the guide wire body. Both welds were present and were observed to be full and spherical. The bend in the guide wire was located 436mm from the proximal tip. The overall length of the guide wire measured 458mm which is within the specification of 450-458mm per guide wire product drawing. The outer diameter of the guide wire measured 0. 86mm which is within the specification of 0. 838-0. 877mm per guide wire product drawing. The guide wire was advanced through the kit ars and a lab inventory 18ga introducer needle to functionally test the guide wire. The guide wire passed through both components with minimal resistance. A manual tug test confirmed that both the distal and proximal welds were intact. A device history record review was performed on the guide wire and no relevant manufacturing issues were identified. The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use. 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 kinked during use was confirmed through examination of the returned sample. The guide wire contained a slight bend on the distal end. The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues. Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event. Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand NameARROW MULTI-LUMEN/PSI SET
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9255435
MDR Text Key164895522
Report Number3006425876-2019-00846
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K002507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSI-11142
Device Lot Number71F18J0798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No

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