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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN031665
Device Problem Material Deformation (2976)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Cardiogenic Shock (2262)
Event Date 05/08/2020
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that the spring wire guide kinked during patient use.
 
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Brand NameARROW CVC SET: 4-LUMEN 8.5FR X 20CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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
9194334854
MDR Report Key10082659
MDR Text Key191821935
Report Number3006425876-2020-00450
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN031665
Device Catalogue NumberEU-15854-CVT
Device Lot Number71F20C2719
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2020
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: 05/22/2020 Patient Sequence Number: 1
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