MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 25 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-16123-F

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the kit was opened and the swg (spring wire guide) was kinked.A new kit was obtained.

Manufacturer Narrative

(b)(4).The customer did not return a complaint sample, however, they supplied two photos showing the kink in the guide wire.The kink is located on the j-bend of the guide wire towards the distal tip.The images show the guide wire retracted into the advancer tube.It cannot be determined if there is evidence of use from the photos.A device history record (dhr) review was performed on the guide wire and no relevant manufacturing issues were identified.The probable cause of the guide wire kinking could not be determined based upon the information provided and without the actual complaint sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges that the kit was opened and the swg (spring wire guide) was kinked.A new kit was obtained.

Manufacturer Narrative

(b)(4).The customer returned the guide wire assembly for evaluation.The guide wire was returned retracted into the advancer assembly and showed evidence of use.The guide wire had one kink on the j-tip on the distal end of the guide wire body.Microscopic examination revealed offset coils at the kink.Both welds were present and were observed to be full and spherical.No damage was observed on the advancer assembly.The kink/offset coil was located 5.5cm from the distal tip.The length and outside diameter (od) of the guide wire were measured and found to be within specification.A manual tug test confirmed that both the proximal and distal welds were intact.A device history record (dhr) review was performed on the guide wire and no relevant findings were identified.The 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 with offset coils 5.5cm from the distal tip.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the kit was opened and the swg (spring wire guide) was kinked.A new kit was obtained.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 25 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6602808
• MDR Text Key: 76395343
• Report Number: 1036844-2017-00230
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CS-16123-F
• Device Lot Number: 23F16F0289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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