MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-26702-E

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The customer reports: "the partita guide is found, which prevents the catheter from passing".

Event Description

The customer reports: "the partita guide is found, which prevents the catheter from passing".

Manufacturer Narrative

(b)(4).The customer returned multiple components from a cvc kit.The guide wire sub-assembly and a 2-lumen catheter will be analyzed for this complaint investigation.Visual examination revealed a slight kink in the guide wire near the distal tip.As a result, the j-tip of the guide wire was slightly deformed and did not have a consistent arc.Microscopic examination confirmed the kink and revealed signs-of-use in the form of biological material between the coils of the guide wire.The distal and proximal welds appeared spherical and intact.No other defects or anomalies were observed.The kink in the guide wire was 27mm from the distal tip.The length and outer diameter of the guide wire were measured and were found to be within specification.The catheter body from the juncture hub to the tip, and the catheter diameter were also within specification.The proximal end of the returned guide wire was passed through the distal tip of the catheter.Minor resistance was encountered when the kink in the guide wire reached the catheter; however, the guide wire was able the pass completely through.A manual tug test was performed on the guide wire.Both welds appeared to be secure in the assembly.A device history record review was performed with no relevant findings to suggest a manufacturing issue.The ifu provided with the kit states, "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 ifu also warns 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 customer complaint of the "swg/catheter resistance - kinked" was confirmed through complaint investigation of the sample.The guide wire was examined, and a kink was found adjacent to the j-tip.Traces of biological material were also observed.Functional testing proved that the returned guide wire could pass completely through the catheter body with minor resistance.The guide wire and catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer description and the returned sample, it was determined that unintentional user 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 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8240319
• MDR Text Key: 132820020
• Report Number: 3006425876-2019-00032
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/12/2019
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F17K0756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.