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U.S. Department of Health and Human Services

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

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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 01/01/2009
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): "a (b)(6) male with idiopathic esrd treated with hemodialysis since 1995 presented for a cadaveric renal transplant 2009. A cvl arrow g+ard blue plus was inserted in the internal jugular vein. Shortly afterwards, the patient's peak airway pressures increased to 32/5 cmh2o and his o2 saturation fell to 92%. Systolic blood pressure transiently decreased from 120 to 100 mmhg and there was an increase heart rate to 70-90 beats/min. A red rash was noted on his chest. The transplantation procedure was completed without further incident. Serum tryptase was not measured".

 
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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 Key8802584
MDR Text Key151436802
Report Number9680794-2019-00278
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 FOREIGN,OTHER
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 Received07/18/2019
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 Received08/27/2019
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: 07/18/2019 Patient Sequence Number: 1
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