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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 THERAPE

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number EDC-00620
Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Migration (4003)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 06/04/2020
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4). Response to additional questions from risk management: was there harm or is the patient fine? pt discharged. Rx anti- coagulants. Keeping watch. What is the patient's current condition? good. Was therapy delayed/interrupted? no. Any medical intervention was required. No. Pt is (b)(6) and is on blood thinners currently. Any concerns about possible migration of the missing catheter tip? perhaps into the lungs - pe is a concern.
 
Event Description
The customer reported: upon catheter removal it was then noted that the catheter tip was rough and missing approximately 0. 5 to 1 cm. Cephalic intra-vascular catheter foreign body with migration. Cath tip was not recovered.
 
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Brand NameARROW EXT DWELL CATH DEVICE 20GAX6CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10148530
MDR Text Key194964746
Report Number9680794-2020-00276
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Catalogue NumberEDC-00620
Device Lot Number14F18K0242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
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