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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 18GAX8CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 18GAX8CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number EDC-00818
Device Problems Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 03/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional information: it is reported the customer pulled the catheter back against the needle bevel which is against ifu.
 
Event Description
The customer reports that the catheter tip sheared off into the patient during insertion.The inserter reports that he realized the catheter was not actually in the vessel when he tried to advance it further into the vessel.Intervention: the patient was sent to surgery to have the tip removed.The surgery was successful.
 
Event Description
The customer reports that the catheter tip sheared off into the patient during insertion.The inserter reports that he realized the catheter was not actually in the vessel when he tried to advance it further into the vessel.Intervention: the patient was sent to surgery to have the tip removed.The surgery was successful.
 
Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied three photos showing the complaint sample.The photos show a product lid stock and the catheter over the needle cannula.The catheter tip appears to have been separated from the rest of the body in the photos.The guide wire is advanced out of the needle bevel and the device shows evidence of use.A probable cause of the catheter separating cannot be determined from the photos and without the sample to evaluate.A device history record review was performed on the endurance device including the catheter assembly and no manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit describes suggested techniques for catheter insertion.The ifu also cautions the user "prior to insertion, distal tip of catheter must be fully retracted past needle bevel or catheter tip damage may occur." it also contains the caution ": always keep needle/handle stationary while threading catheter.Do not retract needle/handle while threading catheter.Failure to keep needle/handle stationary may prevent catheter from threading into vessel." the report that the catheter separated was confirmed through examination of the customer supplied photo.The image showed the catheter tip separated from the rest of the assembly; however, the actual complaint sample was not returned for evaluation.The device history records for the device and catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the catheter damage could not be determined based upon the information provided and without the actual complaint sample.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW EXT DWELL CATH DEVICE 18GAX8CM
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7406572
MDR Text Key105165196
Report Number9680794-2018-00066
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Catalogue NumberEDC-00818
Device Lot Number14F17G0365
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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