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

Catalog Number CV-22854-QE

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device (catalog# cv-22854-qe) is not sold in the us.Similar product/component sold in the us.

Event Description

The customer reports: on insertion of a quad lumen central line guide wire the distal end was noted to be "kinked".Insertion had been with a cannula into the internal jugular vein.It was not possible to remove the cannula sheath due to the kink.

Manufacturer Narrative

(b)(4).The customer returned a guide wire assembly and the product lidstock for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The guide wire was observed to have a kink towards the proximal end of the body.The distal j-bend was slightly deformed but intact.The guide wire was kinked/bent 4 mm from the proximal end tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed with no relevant findings.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.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The returned guide wire met all relevant dimensional requirements and a device history record review 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 unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: on insertion of a quad lumen central line guide wire the distal end was noted to be "kinked".Insertion had been with a cannula into the internal jugular vein.It was not possible to remove the cannula sheath due to the kink.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8335681
• MDR Text Key: 136027282
• Report Number: 3006425876-2019-00093
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CV-22854-QE
• Device Lot Number: 71F18H2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1