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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM MULTI LUMEN ACCESS CATHETERS

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ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM MULTI LUMEN ACCESS CATHETERS Back to Search Results
Catalog Number CDC-21242-1A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Venipuncture (2129)
Event Date 02/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the clinician was inserting the mac during a heart procedure. During insertion of the sheath/dilator they punctured through the vessel.
 
Manufacturer Narrative
(b)(4) device evaluation: the reported complaint of during insertion of the mac sheath and dilator assembly the clinician punctured through the vessel could not be confirmed. The customer returned one dilator. The mac sheath was not returned. Visual examination revealed that the dilator was bent and the tip was damaged. The body begins to bend at 11 cm from the hub base. Microscopic examination revealed that the tip was pushed back on one side creating two divots and a flared piece of the tip material. This type of damage can occur with a difficult insertion. The dilator measured 8. 78 inches length with an outside diameter (od) of 0. 1175inches, which meets the length and od specification for the dilator per graphic. (length: 8. 75- 8. 875inches and 0. 117- 0. 120 inches). This report was reviewed; however a comprehensive investigation could not be performed because the sheath was not returned for analysis and very little information was available on this event. The ifu states to enlarge the cutaneous puncture site with a scalpel prior to dilator insertion. It also warns not to leave the tissue dilator in place as an indwelling catheter to minimize the risk of possible vessel wall perforation. Other remarks: information about the skin nick or dilator use was not reported. A device history record review did not reveal any manufacturing related issues. The probable cause of this complaint 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 NameMAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM
Type of DeviceMULTI LUMEN ACCESS CATHETERS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5505077
MDR Text Key40503236
Report Number1036844-2016-00158
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011761
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 02/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2017
Device Catalogue NumberCDC-21242-1A
Device Lot Number23F15D1462
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2016 Patient Sequence Number: 1
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