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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-27702-E
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the procedure was being performed in the nsicu. During insertion, the guide wire could not be removed smoothly. Upon removal it was found to be unraveled. As a result, a new kit was used successfully. There was a delay in treatment with no patient harm and no patient death or complications reported.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the guide wire unraveled was confirmed. Returned were a guide wire and a guide wire advancer. No other components were received. The customer also provided photos of the sample. The guide wire was unraveled at the distal end. The core wire was separated adjacent to the weld at the distal end. Discoloration was observed at the broken end of the core wire, which is consistent with proximity to a weld. Microscopic inspection revealed a plastic deformation and necking of the wire in the area of the break. The distal weld was missing from the distal end of the coil wire. A manual tug test confirmed that the proximal weld is intact. The core wire measured approximately 60 cm in length. Based upon the measured length of the broken core wire, no pieces of the core wire appear to be missing. The od of the guide wire measured 0. 795 mm. This met specification of 0. 788 - 0. 826 mm per the guide wire graphic. The instruction booklet provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use. It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel. In this case it is recommended to withdraw the other remarks: catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire. The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire. The device history records were reviewed with no relevant findings. The investigation found no evidence to suggest a manufacturing related cause. The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking. Guide wire breakage may occur if a force greater than the design specification is applied during removal. Based on these circumstances, operational context caused or contributed to this event. No further action will be taken.
 
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Brand NameCVC SET: 2-LUMEN 7 FR X 20 CM
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 Key5853732
MDR Text Key51841009
Report Number1036844-2016-00462
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
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 07/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberCS-27702-E
Device Lot Number23F15J0682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2015
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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