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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN/PSI SET INTERVENTIONAL PSI PRODUCTS

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ARROW INTERNATIONAL INC. MULTI-LUMEN/PSI SET INTERVENTIONAL PSI PRODUCTS Back to Search Results
Catalog Number SI-11142
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2016
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4). The event was initially evaluated and determined to be non-reportable. The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore it is reportable.
 
Event Description
It was reported that during insertion in ane, the md was unable to advance the guide wire through the ars. As a result, a new kit was opened and used without issue. There was no reported delay, death, or complications to the patient as a result of this occurrence.
 
Manufacturer Narrative
(b)(4). Device evaluation: it was reported that the md was unable to advance the guide wire through the ars was confirmed. One opened si-11142 kit, containing a guide wire and numerous other components, was returned. The arrow raulerson syringe (ars) was not returned. The returned guide wire was observed to be kinked 2 cm from the j-tip. Microscopic evaluation also found an offset coil located 1 cm from the j-tip weld. Both welds were observed to be full and spherical. A manual tug test confirmed that both welds remain intact and the wire feels typical. The guide wire graphic specifies an outside diameter of. 838/. 877 mm and a length of 454 +/- 4 mm. The guide wire length was measured at 456 mm. The outside diameter measured. 854 mm. Both measurements met specifications. The instructions booklet provided with the kit, describes suggested techniques to minimize the likelihood of guide wire damage during use. A device history record review was performed and did not reveal any manufacturing related issues. The probable cause of this issue could not be determined without a complete sample. No further action will be taken.
 
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Brand NameMULTI-LUMEN/PSI SET
Type of DeviceINTERVENTIONAL PSI 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 Key6132581
MDR Text Key61035375
Report Number3006425876-2016-00370
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K002507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberSI-11142
Device Lot Number71F15D0717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2015
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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