MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-25703-E

Device Problems Folded (2630); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports during insertion, the doctor could not advance the swg (spring wire guide) due to the folded swg line.Another device was used and the procedure was completed successfully.

Manufacturer Narrative

(b)(4).The customer returned a guide wire assembly, an 18ga introducer needle, an arrow raulerson syringe (ars) and the product lid stock for evaluation.The guide wire was returned retracted within the advancer tube and showed evidence of use.The guide wire was observed to have two bends/kinks towards the distal end of the body.The distal j-bend was slightly deformed but intact.The insertion components (ars and introducer needle) showed evidence of use but no defects or anomalies.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The bends/kinks in the guide wire were located 25 and 39mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The introducer needle inner and outer diameters were also measured and were within specification.The guide wire was advanced through the returned ars and 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.Other remarks: a device history record review was performed on the guide wire assembly and no relevant 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 bent/kinked in two locations towards the distal tip.The returned guide wire and insertion components (ars and introducer needle) met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the returned components 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 reports during insertion, the doctor could not advance the swg (spring wire guide) due to the folded swg line.Another device was used and the procedure was completed successfully.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 7185774
• MDR Text Key: 97089443
• Report Number: 3006425876-2018-00041
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F17F1386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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