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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 Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Preliminary investigation of the returned device indicates spring wire guide/catheter resistance - kinked.
 
Event Description
When passing the central venous catheter, the guide advances in a normal way, when passing the dilator, it folds the guide, being trapped, damaging the guide and preventing the catheter from advancing. This case is presented twice in the same patient with a product of the same reference and the same batch.
 
Manufacturer Narrative
(b)(4). The customer returned a used 3-l 7 fr x 20 cm cvc kit catheter with the spring wire guide (swg) still inside of the catheter. The swg was removed from the catheter. The swg was in a u shape with multiple kinks and offset coils in the swg body. The distal j-bend appeared undamaged and both the proximal and distal welds appeared intact, full, and spherical. Bends were found in the catheter body; however, the bends were in the same shape as the kinked swg and most likely formed as a result of the swg remaining in the catheter. Prominent kinks in the swg body were located approximately 185 mm and 355 mm-41mm from the distal weld. Bends in the catheter body were located approximately 50 mm-100mm from the distal end of the juncture hub. The swg body length and outer diameter were measured and were found to be within specification. The catheter body length and outer diameter were also within specification. A swg with an od of 0. 843 mm from lab inventory passed through the returned catheter from the hub to the tip without restriction. This indicates that a swg with an od of 0. 798 mm would be able to pass through the catheter as well. A manual tug test confirmed the distal weld and proximal welds were intact. A device history review was performed and no manufacturing issues were identified. The in structions-for-use states that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement the catheter should be withdrawn 2-3 cm relative to the spring-wire guide and another attempt should be made to remove it. If resistance is felt again the spring-wire guide and catheter should be removed simultaneously. Applying undue force may cause the spring-wire guide to break. The reported complaint that the guide wire kinked while using the catheter was confirmed through visual examination of the returned sample. The returned guide wire body had multiple kinks and offset coils. A lab inventory swg with an od of 0. 843 mm advanced through the returned catheter from the hub to the tip without restriction. This indicates that a swg with an od of 0. 798 mm would be able to pass through the catheter as well. The returned guide wire and catheter met all relevant dimensional/functional requirements and a device history record review did not identify any manufacturing related issues. Based on investigation of the returned sample, it was determined that unintentional use error caused or contributed to this issue. Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
The customer reports: when passing the central venous catheter, the guide advances in a normal way, when passing the dilator, it folds the guide, being trapped, damaging the guide and preventing the catheter from advancing. This case is presented twice in the same patient with a product of the same reference and the same batch.
 
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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
MDR Report Key8350039
MDR Text Key136617209
Report Number3006425876-2019-00143
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
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 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/03/2020
Device Catalogue NumberCV-25703
Device Lot Number71F18C1409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No

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