MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-27702-E

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The customer alleges that the guide wire was curved and could not be used.The doctor use another set and completed the procedure without issue.

Manufacturer Narrative

(b)(4).Catalog # corrected to cs-27702-e.The customer returned a single guide wire for evaluation.The returned guide wire showed evidence of use.The guide wire was observed to have a single kink towards the distal end of the body.The distal j-bend was observed to be undamaged.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The kink in the guide wire was located 28 mm from the distal tip.The overall length and outer diameter of the guide wire were measured and found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record (dhr) review was performed on the guide wire and insertion components (ars and introducer needle) and no relevant manufacturing issues 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 in one location towards the distal end of the body.The returned guide wire met all relevant dimensional requirements and a dhr review did not identify any manufacturing related issues.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.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges that the guide wire was curved and could not be used.The doctor use another set and completed the procedure without issue.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6827963
• MDR Text Key: 83899030
• Report Number: 3006425876-2017-00354
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F16M1278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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