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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer did not return the actual sample; however, they did return a representative sample kit from lot#23f17b0357. No defects or anomalies were observed on the catheter or guide wire from the representative kit. The representative sample passed all relevant dimensional requirements. The guide wire was also advanced through the other insertion components with minimal resistance. All components functioned as expected. A manual tug test performed on the representative sample confirmed both the distal and proximal welds are intact. A device history record review was performed on the guide wire and catheter and no relevant findings were identified. Other remarks: the instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use. The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel. In this circumstance, withdraw the catheter relative to the spring wire guide about 2-3cm and attempt to remove the spring wire guide. If resistance is again encountered, remove the spring wire guide and catheter simultaneously. Complaint verification testing could not be performed as the actual complaint sample was not returned for analysis. A representative sample was returned and met all relevant visual, dimensional and functional requirements. A dhr review was performed and no relevant findings were identified. Without the actual complaint device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer alleges that the spring wire guide would not pass the entire way through the cvc. The wire is not coming apart, just bunching up in the procedure. Therapy was not delayed.
 
Manufacturer Narrative
(b)(4). The device sample was received by the manufacturer, but the investigation results are pending at the time of this report.
 
Event Description
The customer alleges that the spring wire guide would not pass the entire way through the cvc. The wire is not coming apart, just bunching up in the procedure. Therapy was not delayed.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6669566
MDR Text Key202515039
Report Number1036844-2017-00246
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F17B0357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2017
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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