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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 8FR X 20CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 8FR X 20CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number DE-25802-MARL
Device Problems Kinked (1339); Split (2537); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2016
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4). Additional information: this product is not sold in the us. The 510k # provided is for a similar product that is sold in the us.
 
Event Description
It was reported that the event occurred at the anesthesia/op. In the blood vessel it was difficult to advance the guide wire and the wire kinked. The dilator split due to rough skin. No incision was performed.
 
Manufacturer Narrative
(b)(4). Device evaluation: the report that the guide wire kinked was confirmed. Returned were a guide wire and a dilator. The dilator body was slightly bent at the tip. Under microscopic examination, the distal tip of the dilator was slightly pushed back in one location. There were white regions in the tip, indicating that it had been exposed to stress. There were kinks in the guide wire at 15, 25. 5, and 30 cm from the bottom of the j-bend. A manual tug test confirmed that both welds were intact. The length of the guide wire measured approximately 60. 1 cm. The length of the guide wire was consistent with the guide wire graphic. The outside diameter (od) of the guide wire measured 0. 800 mm, which met specification of 0. 788 - 0. 826 mm per the guide wire graphic. The inside diameter (id) of the dilator tip could not be measured due to the damage. The proximal end of the guide wire was inserted into the distal tip of the dilator and the dilator met resistance at the first kink in the wire. The instruction booklet provided with the kit describes an insertion procedure including the step to enlarge the cutaneous puncture site with the cutting edge of a scalpel prior to dilating. The customer reported that no incision was performed. The device history records were reviewed with no evidence other remarks: to suggest a manufacturing related issue. The damage to the guide wire and dilator is characteristic of encountering resistance during insertion. Based on the condition of the sample and the report that it occurred during insertion, operational context caused or contributed to this event. No further action will be taken.
 
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Brand NameCVC KIT: 2-LUMEN 8FR X 20CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
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
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key6114200
MDR Text Key60385507
Report Number3006425876-2016-00363
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K900263
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 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue NumberDE-25802-MARL
Device Lot Number71F16G0704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2016
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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