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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PSI KIT: 9 FR X 10 CM ANTIMICROBIAL ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. PSI KIT: 9 FR X 10 CM ANTIMICROBIAL ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-29903-1A
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report is for the first in a series of two consecutive product problems with the same patient. The second issue has been reported under mdr # 1036844-2016-00425.
 
Event Description
It was reported the clinician experienced difficulty when floating the edwards 8fr swan through the sheath. As a result, another sheath was used. It was noted the catheter was snug during insertion but they were able to insert the catheter. The sheath was snug pushing it through the sheath and perforated balloon. The anesthesiologist feels forcing the catheter through the sheath and the perforated swan. The procedure was converted from minimally invasive to a sternotomy. The procedure was being performed on a (b)(6) female patient. This involved two catheters. For the first catheter the balloon ruptured during insertion. It was difficult passing through the sheath. As a result, a second catheter was used.
 
Manufacturer Narrative
(b)(4). Device evaluation: it was reported that difficult floating the catheter through the sheath, resulting in perforating the balloon was confirmed. One edwards swan ganz cco/mbo/vip 1. 5 ml cap 746f8 catheter inserted through a cath-gard contamination shield was returned. The psi sheath involved in the incident was not returned. Microscopic inspection of the catheter confirmed that the balloon was torn. The catheter body diameter was measured at 2. 84 mm. The edwards website indicates that the catheter is 8 fr. Per the lidstock, the arrow sheath/cath-gard is designed for use with 7. 5 - 8 fr catheters. The catheter was removed from the cath-gard and reinserted with minor resistance at the connectors. The balloon on the catheter was confirmed to be torn but verification testing could not be performed because the sheath was not returned. A device history record review was performed and did not reveal any manufacturing related issues. The probable cause of this issue could not be performed based on the information provided and without a complete sample. No further action will be taken.
 
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Brand NamePSI KIT: 9 FR X 10 CM ANTIMICROBIAL
Type of DeviceARROWG+ARD CATHETER PRODUCTS
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
MDR Report Key5805065
MDR Text Key49955088
Report Number1036844-2016-00426
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 07/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberCDC-29903-1A
Device Lot Number23F16A0846
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2016
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: 07/19/2016 Patient Sequence Number: 1
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