• 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. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER, INTRAVASCULAR, THERAP.

  • 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. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER, INTRAVASCULAR, THERAP. Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problems Kinked (1339); Material Too Rigid or Stiff (1544); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports the doctor having issue with the guide wire. It becomes very stiff and difficult to pass through the introducer. In some cases, it is so difficult that they can't pass it though ending up kinking.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports the doctor having issue with the guide wire. It becomes very stiff and difficult to pass through the introducer. In some cases, it is so difficult that they can't pass it though ending up kinking.
 
Manufacturer Narrative
(b)(4). The customer returned one guide wire for evaluation. The introducer needle was not returned. Visual examination revealed the guide wire body was kinked/bent near the center. The distal j-bend was undamaged. Microscopic examination of the guide wire confirmed the kink and revealed offset coils at the location of the kink. Both welds appeared intact, full and spherical. The kink (with offset coils) in the guide wire body was located approximately 244 mm from the proximal weld. The overall length and outer diameter of the guide wire were measured and were found to be within specification. A manual tug test confirmed that both the distal and proximal welds were intact. A device history record review was performed and no relevant manufacturing issues were identified. The instructions-for-use (ifu) provided with this kit describes suggest techniques for insertion to minimize damage to the guide wire during use. 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 reported complaint of the guide wire becoming kinked while using the introducer needle was confirmed through visual inspection of the returned sample. A single kink was observed on the returned guide wire; however, the introducer needle was not returned for evaluation. A device history record review did not reveal any manufacturing related issues. No manufacturing defects were found during this investigation. Based on these circumstances, operational context likely contributed to this event, however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned.
 
Event Description
The customer reports the doctor having issue with the guide wire. It becomes very stiff and difficult to pass through the introducer. In some cases, it is so difficult that they can't pass it though ending up kinking.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceCATHETER, INTRAVASCULAR, THERAP.
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7513931
MDR Text Key108252982
Report Number1036844-2018-00143
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F17L0792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-