• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW - UNKNOWN CATHETER, PERCUTANEOUS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ARROW - UNKNOWN CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Reaction (2414)
Event Date 01/01/2008
Event Type  Injury  
Manufacturer Narrative

(b)(4). The specific event date, customer facility name/contact information, product code, lot#, patient condition and sample availability are all unknown. No further action is required at this time. If additional information is provided the complaint will be updated accordingly.

 
Event Description

According to a case report in an article - canadian anesthesiologists society from 2019 for events that occurred in (b)(6): "this (b)(6) male with end-stage renal disease (esrd) secondary to hypertension and type-ii diabetes presented for renal transplantation in 2008. He had been on hemodialysis via an arterio-venous (av) arm fistula for six years. At that initial transplant operation, he received basiliximab pre-treatment followed by induction of anesthesia using midazolam, fentanyl, propofol and rocuronium. Shortly after cvl placement, the patient developed profound hypotension that progressed to a pulseless electrical activity (pea) cardiac arrest with a narrow complex tachycardia and st-segment depression, the operation was cancelled. Allergy skin tests to cefazolin, rocuronium and latex gave negative results as did immunocap testing for latex-specific ige. Basiliximab could not be obtained for skin testing and chx testing was also not performed".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW - UNKNOWN
Type of DeviceCATHETER, PERCUTANEOUS
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
keely mckinley
3015 carrington mill blvd
morrisville, NC 27560
9194334889
MDR Report Key8799327
MDR Text Key151334495
Report Number9680794-2019-00275
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberVASCULAR UNKNOWN
Device LOT NumberUNKNOWN
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 Received08/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/17/2019 Patient Sequence Number: 1
-
-