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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number EU-25853-CVT
Device Problems Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Preliminary evaluation of the returned device indicates swg/catheter resistance - kinked. The device product is not intended for sale in the us. Similar device sold in the us. A device history record review was performed on the catheter and guide wire and no relevant manufacturing issues were identified. The instructions-for-use (ifu) provided with this product ((b)(4)) 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 2-3 cm and attempt to remove the spring-wire guide. If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.
 
Event Description
The customer reports it was not possible to advance the cvc over the swg (spring wire guide); a resistance was noted.
 
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Brand NameARROW CVC SET: 3-LUMEN 8.5FR X 20CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7610652
MDR Text Key111440343
Report Number3006425876-2018-00414
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberEU-25853-CVT
Device Lot Number71F18B0433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2018
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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