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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-45703-P1A
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer did not return a complaint sample; however, they supplied a photo showing 2 kinks in the guide wire. The kinks are located along the body of the guide wire. The images show evidence of use on the guide wire. A device history record (dhr) review was performed on the guide wire and catheter and no relevant findings were identified. The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use. The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage. If resistance is encountered, 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. Other remarks: the report that the guide wire kinked was confirmed through examination of the customer supplied photo. The image showed the guide wire kinked in several locations along the body; however, the actual complaint sample was not returned for evaluation. The dhr review for the guide wire and catheter were reviewed with no evidence to suggest a manufacturing related cause. The probable cause of the guide wire kinking could not be determined based upon the information provided and without the actual complaint sample. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports that while the wire was being removed from the catheter, it would get stuck and could not be removed. One incident, the md pulled and the wire finally came out. The wire was extremely kinked. Another one had to remove the catheter because the wire was stuck". There was no injury or consequence to the patient reported. The patient's condition is reported as "fine". Therapy was reported to have been delayed/interrupted due to the alleged defect.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that while the wire was being removed from the catheter, it would get stuck and could not be removed. One incident, the md pulled and the wire finally came out. The wire was extremely kinked. Another one had to remove the catheter because the wire was stuck". There was no injury or consequence to the patient reported. The patient's condition is reported as "fine". Therapy was reported to have been delayed/interrupted due to the alleged defect.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6707483
MDR Text Key176781107
Report Number3003737899-2017-00067
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
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 07/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberCDC-45703-P1A
Device Lot Number13F16K0326
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2016
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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