• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" ARROWG+ARD CATHETER PRODUCTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number ASK-45703-PHF2
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when removing the guide wire from the catheter, the guide wire unraveled. The guide wire was removed in its entirety, however, the catheter was able to remain in place. It was not known if this caused a delay, however, there was no reported delay, death, or complications to the patient as a result of this occurrence.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the guide wire unraveled was confirmed. Returned was one guide wire. The catheter was not returned. The guide wire was kinked 39 cm from the distal tip. 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 appears full and remains attached to the unbroken coil wire. A manual tug test confirmed that the proximal weld is intact. The core wire measured approximately 60. 4 cm in length. Based upon the measured length of the broken core wire, no pieces appear to be missing. The od of the guide wire measured 0. 790 mm. This met specification of 0. 788 - 0. 826 mm per 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 catheter relative to the guide wire about 2-3 cm and then attempt to remove other remarks: 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 for the guide wire 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
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 Key5848435
MDR Text Key51242389
Report Number1036844-2016-00450
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
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 07/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberASK-45703-PHF2
Device Lot Number23F16C0245
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-