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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPRING WIRE GUIDE COMPON ENT SPRING WIRE GUIDE PRODUCTS

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ARROW INTERNATIONAL INC. SPRING WIRE GUIDE COMPON ENT SPRING WIRE GUIDE PRODUCTS Back to Search Results
Catalog Number AW-14735
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion in the icu, resistance was met when inserting the guide wire through the ars. As a result, a new kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
(b)(4). Device evaluation: it was reported that during insertion, resistance was met when inserting the guide wire through the ars was not confirmed. Returned were a guide wire and an advancer. The ars was not returned. The customer also supplied a photo of the sample in the kit. The guide wire was kinked 1. 2cm from the bottom of the j-bend. The od of the guide wire measured 0. 847mm. This met specification of 0. 838 - 0. 877 mm per guide wire graphic. The length of the guide wire measured 68. 5cm, which was also consistent with the guide wire graphic. A manual tug test confirmed that both welds were intact. The guide wire was inserted into the ars and introducer needle from lab inventory four times with the plunger in and then out, rotating the sample 1/4 turn each time. No resistance was experienced passing the guide wire through the ars and needle. A review of the device history records for the guide wire and ars did not reveal any manufacturing related issues. The probable cause of resistance inserting the guide wire could not be determined based upon the information provided and without a complete sample. No further action will be taken.
 
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Brand NameSPRING WIRE GUIDE COMPON ENT
Type of DeviceSPRING WIRE GUIDE PRODUCTS
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
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5853197
MDR Text Key51371767
Report Number9680794-2016-00138
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K970864
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 07/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue NumberAW-14735
Device Lot Number14F15A0464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2015
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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