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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 8.5 FR X 10 CM INTRODUCER CATHETER

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ARROW INTERNATIONAL INC. ARROW PSI KIT: 8.5 FR X 10 CM INTRODUCER CATHETER Back to Search Results
Catalog Number CDC-09803-1A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: 1240-05)qn#1900080442. Medwatch uf/importer report# 2000330000-2020-8051.
 
Event Description
Medwatch report received: "from staff: patient turned side to side. Change in pulmonary artery catheter waveform noted, at same cm marking of 54cm. Noticed right internal jugular (ij) vein central venous catheter inadvertently pulled out partially. Dr on unit and advanced line at bedside, stat chest x-ray done to confirm placement of ij & swanganz line. No change in vital signs during this, all meds infusing through swan. " no patient harm reported. Device continued to be used after being repositioned by the cardiac surgeon.
 
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Brand NameARROW PSI KIT: 8.5 FR X 10 CM
Type of DeviceINTRODUCER CATHETER
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 Key10848216
MDR Text Key216629681
Report Number9680794-2020-00457
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K780532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue NumberCDC-09803-1A
Device Lot Number13F19K0445
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 Received12/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2019
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: 11/16/2020 Patient Sequence Number: 1
Treatment
SWAN GANZ - TORQUE-LINE THERMODILUTION CATHETER (4
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