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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-26702-E
Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "patient in whom an ultrasound-guided central catheter is placed, left subclavian jugular via without complications, at the moment of removing the guide cannot be removed, it remains trapped, insists on its removal evidence that it's lost his memory at the end proximal, and it's unrolled, at the risk of staying inside the patient. It's tracked, presenting at the same time withdrawal of the guide and withdrawal of the vascular device (the guide is strongly adhered to the catheter). " no medical intervention was required. The device was removed and replaced. It was reported there was a delay in therapy without harm to the patient.
 
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Brand NameARROW CVC SET: 2-LUMEN 7FR X 20CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key14189430
MDR Text Key289961552
Report Number3006425876-2022-00341
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCV-26702-E
Device Lot Number71F21F0388
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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