• 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 AM PICC SET: 2-L 5.5FR X 55CM 130CM HYDR CATHETER, INTRAVASCULAR, THERAPEUTIC

  • 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 AM PICC SET: 2-L 5.5FR X 55CM 130CM HYDR CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CS-25123-F
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer returned a single guide wire and the product lidstock for evaluation. It was observed that there was one significant kink at the center of the guide wire body. The guide wire between the kink and the distal tip was curled and twisted. The distal tip was intact but did not retain its j-bend shape. Microscopic examination confirmed the kink in the guide wire body. Both welds were present and were observed to be full and spherical. The guide wire was kinked 36. 6cm from the proximal tip. The guide wire was twisted/curled between 36. 6-54. 9cm from the proximal tip. The overall length and outer diameter (od) of the guide wire were measured and found to be within specification. A manual tug test confirmed that both the proximal and distal welds were intact. A device history record (dhr) review was performed on the guide wire and catheter and no relevant manufacturing issues were identified. The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage 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. Other remarks: the report that the guide wire kinked during use was confirmed through examination of the returned sample. The guide wire was kinked at the center of the body and twisted/curled towards the distal end. The returned guide wire met all relevant dimensional requirements. A dhr review was performed and did not identify any manufacturing related issues. Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.
 
Event Description
The customer alleges that during insertion, the spring wire guide kinked.
 
Manufacturer Narrative
(b)(4). The device sample was received by the manufacturer, but the investigation is not complete at the time of this report.
 
Event Description
The customer alleges that during insertion, the spring wire guide kinked.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW AM PICC SET: 2-L 5.5FR X 55CM 130CM HYDR
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6756970
MDR Text Key195857489
Report Number3006425876-2017-00236
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue NumberCS-25123-F
Device Lot Number71F16L2183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-