MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CS-12122-F

Device Problems Complete Blockage (1094); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the doctor found the sheath blocked and the catheter could not advance during use on a patient.The device was replaced, and procedure completed without incident.

Event Description

The customer reports that the doctor found the sheath blocked and the catheter could not advance during use on a patient.The device was replaced , and procedure completed without incident.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened hemodialysis catheterization set included 2-l ctheter, swg, dilator, ars/needle, and lidstock for evaluation.Visual examination of the guide wire revealed on small kink inside the distal j-bend.Both welds of the wire appeared full and spherical.No other defects or anomalies were observed on the returned components.The kink in the guide wire measured 8mm.The overall length of the guide wire measured 601mm which is within specification of 596-604mm per product drawing.The outer diameter of the guide wire measured 853mm which is within specification of.838-.877mm per product drawing.The overall length of the catheter body measured 168mm which is within specification of 157-177mm per product drawing.The returned guide wire passed through the returned catheter, the returned dilator and the returned ars attached to the returned introducer needle with minimal resistance.A manual tug test confirmed both welds were intact on the guide wire.A dhr review was completed with no relevant findings.The ifu provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire kinked during use was confirmed through examination of the returned sample.A small kink inside the distal j-bend was observed.The returned guide wire and catheter met all relevant dimensional requirements and a device history record 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, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9175434
• MDR Text Key: 166995696
• Report Number: 3006425876-2019-00779
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F16K0517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN,; UNKNOWN.