MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

When the md tried to insert swg (spring wire guide), it did not come out so could not be inserted.The swg was kinked.Md was unable to proceed with the product so used new product.

Manufacturer Narrative

Qn#(b)(4).The customer returned one spring wire guide (swg) within its advancer tubing, ars and introducer needle, and a dilator for evaluation.Visual inspection of the swg revealed a slightly misshaped j-bend.This is most-likely due to the swg being retracted inside the advancer tubing during shipping.No other defects or anomalies were observed.Microscopic examination of the swg confirmed that both welds were in place.The total length of the swg measured 602 mm, which is within specifications of 596-604 mm per swg graphic.The outer diameter of the swg measured 0.792 mm which is within specifications of 0.788-0.826 mm per swg graphic.The swg was inserted into the returned ars, the returned introducer needle, and the returned dilator to functionally test.The swg passed through all three with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheter.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report that the spring wire guide was found to be kinked in use was not able to be confirmed through the complaint investigation of the returned sample.The returned guide wire had a slightly misshaped j-bend but this is most likely due to it being completely retracted in the advancer tubing during return shipping.No other defects or anomalies were found.The returned guide wire met all relevant dimensional requirements and a device history record review was completed and did not identify any manufacturing related issues.Based on the guide wire returned, no problem was found.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

When the md tried to insert swg (spring wire guide), it did not come out so could not be inserted.The swg was kinked.Md was unable to proceed with the product so used new product.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10178672
• MDR Text Key: 195942726
• Report Number: 3006425876-2020-00539
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2021
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F19C2466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.