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 Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the preliminary evaluation of the returned device sample it is observed that the spring wire guide was kinked.

Event Description

The customer alleges the swg (spring wire guide) could not pass through the ars (syringe).

Manufacturer Narrative

(b)(4).The customer returned an opened cs-25802-e kit containing a guide wire, arrow raulerson syringe (ars) and introducer needle for evaluation.The guide wire was returned advanced through the ars and introducer needle which showed evidence of use.The ars was able to be advanced off the guide wire with minimal resistance during decontamination.Resistance was met when attempting to withdraw the needle.Visual examination of the sample revealed that the distal end of the guide wire was advanced through the introducer needle.The guide wire was observed to have a single kink on the proximal side of the needle near the center of the guide wire body.The distal j-bend was slightly deformed but intact.Dried blood was observed in the ars tip and in the introducer needle hub but no other damage to the components was observed.Microscopic examination confirmed the kink in the guide wire body.No obvious friction points were observed at the point where the guide wire entered the needle hub or exited the needle bevel.Both welds were present and were observed to be full and spherical.The introducer needle was able to be advanced off the guide wire without damaging the components, although significant force was required.Dried blood was observed to be covering the guide wire body where the needle cannula was stuck, indicating the blood was causing the resistance.The guide wire body was kinked 354mm from the proximal tip.A length of 60mm of the distal end of the guide wire was advanced out the needle bevel.The length and outer diameter of the guide wire were measured and were found to be within specification.The inner diameter of the introducer needle cannula was also with specification.The ars was able to be advanced off the guide wire during decontamination.Initially the introducer needle was stuck but it was able to be advanced off the guide wire without damaging the components, although significant force was required.After cleaning the guide wire and introducer needle of dried blood the guide wire was able to fully pass through the introducer needle and ars with minimal resistance.Therefore, it can be concluded the dried blood was causing the resistance between the components.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 insertion components (introducer needle and ars) and no relevant findings were identified.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 guide wire was kinked 35.4cm from the proximal tip.The returned guide wire, introducer needle and ars all met all relevant functional/dimensional requirements and a device history record review did not identify any manufacturing related issues.After being cleaned of dried blood, the returned guide wire was able to pass through the ars with minimal resistance.Based on the condition of the returned guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges the swg (spring wire guide) could not pass through the ars (syringe).

• 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
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7219855
• MDR Text Key: 98425122
• Report Number: 1036844-2018-00060
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 23F17F0591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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