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

Catalog Number CV-12122-UF

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that after the dialysis catheter was in place, the physician tried to withdraw the swg (spring wire guide).This wasn't easy and the physician noticed that the swg was damaged making it difficult to remove.The swg was successfully removed entirely.

Manufacturer Narrative

(b)(4).The customer returned the lidstock and an unraveled guide wire from a cv-12122-uf kit.The both the distal and proximal weld were found to be detached from the inner core wire.The outer coil wire was in one piece, indicating that none was missing.The welds and ends of the inner core wire were microscopically examined and signs of the inner core wire necking and fracturing were observed.The inner core wire was measured and found to be within specification.Functional inspection could not be performed as the returned spring-wire guide was unraveled and the catheter was not returned for evaluation.A device history record (dhr) review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel.In this circumstance, 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 was damaged was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal and proximal welds.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:1999 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, it was determined that operational context likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned.

Event Description

The customer alleges that after the dialysis catheter was in place, the physician tried to withdraw the swg (spring wire guide).This wasn't easy and the physician noticed that the swg was damaged making it difficult to remove.The swg was successfully removed entirely.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER, HEMODIALYSIS,NON-IMPLANT
• 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: 6838078
• MDR Text Key: 84368413
• Report Number: 3006425876-2017-00384
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: CV-12122-UF
• Device Lot Number: 71F13K1802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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
• Patient Age: 85 YR