MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-25802-E

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the swg (spring wire guide) was kinked and unable to insert into the patient.

Event Description

The customer reports that the swg (spring wire guide) was kinked and unable to insert into the patient.

Manufacturer Narrative

Qn#(b)(4).The customer returned one spring-wire guide assembly and a 2-lumen cvc catheter for analysis.Signs-of-use in the form of biological material was observed on the catheter and guide wire body.Visual analysis revealed three major kinks and one slight bend across the guide wire body.Additionally, the distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks and revealed that the distal and proximal welds were secure and intact.The major kinks in the guide wire measured 240mm, 252mm, and 573mm respectively from the proximal end.The slight bend in the guide wire measured approximately 325mm from the proximal end.The total guide wire length measured 601mm, which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.79mm, which is within the specification limits of.788mm-.826mm per the guide wire graphic.The guide wire was passed through the returned catheter.Minor resistance was observed at the kinks; however, the guide wire was able to pass completely through the catheter.A manual tug test confirmed that the proximal and distal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide".The ifu also cautions, "pulling back on the spring-wire guide may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw catheter relative to spring-wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed three major kinks and one slight bend on the guide wire body.The distal j-bend was also deformed.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9546848
• MDR Text Key: 179717318
• Report Number: 3006425876-2020-00043
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2020
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F18M1690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 103