MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-22854

Device Problems Difficult to Flush (1251); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that they could not flush the catheter despite having drawn back blood.On removal of the wire it was noted to be bent/kinked.

Manufacturer Narrative

(b)(4).The customer returned one segment of guide wire for evaluation.The returned segment appears to be the distal end as a j-tip is present.The returned piece of guide wire contained multiple kinks with offset coils.The wire contained signs of use in the form of biological material on the exterior of the wire.The wire appears to be cut as the core wire has a straight edge at the point of separation.The returned portion of guide wire measured 77 mm in length, indicating 519-527 mm are missing per length specifications.The outer diameter of the returned portion of guide wire was found to be within specification.A manual tug test confirmed the distal weld is still intact.A device history record (dhr) review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the customer returned one portion of guide wire for evaluation.The guide wire contained signs of use and multiple kinks.A manual tug test confirmed the distal weld was still fully intact.A dhr review was performed with no relevant findings to suggest a manufacturing related issue.The probable cause could not be determined as the entire guide wire was not returned.

Event Description

The customer reports that they could not flush the catheter despite having drawn back blood.On removal of the wire it was noted to be bent/kinked.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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 Key: 6947660
• MDR Text Key: 89719175
• Report Number: 3006425876-2017-00453
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/26/2019
• Device Catalogue Number: CV-22854
• Device Lot Number: 71F17E0698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1