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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number EDC-00620
Device Problems Cut In Material (2454); Physical Resistance (2578)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer. No relevant findings were identified. Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports: "20ga 6cm endurance catheter involved. Clinician inserted catheter into antecubital on male patient. Got blood flash, advanced catheter slightly and then advanced wire without issue. Started to advance catheter over needle and before getting completely in, met resistance and could not fully advance catheter. Clinician inadvertently re-advanced wire through catheter and severed 4cm of catheter off into the patient vein. He removed the endurance unit with 2cm of catheter left. Patient was taken to surgery and surgeon performed a cut down to try and retrieve catheter without success. A vascular surgeon was called for advice and advised to leave patient as is if patient was not presenting with any issues. Patient is fine but catheter remains in patient". There is no patient injury or consequence. Therapy was not delayed/interrupted.
 
Manufacturer Narrative
(b)(4).
 
Event Description
"20ga 6cm endurance catheter involved. Clinician inserted catheter into antecubital on male patient. Got blood flash, advanced catheter slightly and then advanced wire without issue. Started to advance catheter over needle and before getting completely in , met resistance and could not fully advance catheter. Clinician inadvertently re-advanced wire through catheter and severed 4cm of catheter off into the patient vein. He removed the endurance unit with 2cm of catheter left. Patient was taken to surgery and surgeon performed a cut down to try and retrieve catheter without success. A vascular surgeon was called for advice and advised to leave patient as is if patient was not presenting with any issues. Patient is fine but catheter remains in patient". There is no patient injury or consequence. Therapy was not delayed/interrupted.
 
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Brand NameARROW EXT DWELL CATH DEVICE 20GAX6CM
Type of DeviceCATHETER INTRAVASCULAR THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7241620
MDR Text Key285808450
Report Number9680794-2018-00030
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K151513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEDC-00620
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/05/2018 Patient Sequence Number: 1
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