MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, HEMODIALYSIS, NON-I

Catalog Number CV-12142-UF

Device Problems Unraveled Material (1664); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary evaluation of the returned device indicates spring wire guide/needle resistance - unraveled.

Event Description

It was reported that insertion of a dialysis catheter by a physician intern and a senior physician: during insertion, it was impossible to advance the swg completely and to remove it from the needle.A new catheter has been inserted.

Manufacturer Narrative

(b)(4).The customer returned one guide wire and introducer needle for evaluation.Both components showed evidence of use in the form of dried blood.The guide wire was returned partially advanced through the introducer needle.Visual examination revealed the guide wire was unraveled from the distal weld.The core wire was broken adjacent to the distal weld.The exposed distal core wire tip is tapered and discolored at the point of separation.The distal weld contained signs of necking, indicating undue force caused the breakage.Both welds were present and appeared full and spherical.The returned introducer needle shows evidence of use but no obvious defects or anomalies.The inner diameter of the introducer needle cannula measured 0.041" which is within specifications.The outer diameter of the returned guide wire measured to be 0.037" which is within specifications.A lab inventory guide wire passed through the returned introducer needle with minimal resistance.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not cut spring-wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report of an unraveled guide wire was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and introducer needle met all functional/dimensional requirements during investigation testing.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 11070:2014 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.Quarterly trending indicates a low, stable rate for unraveled guide wire complaints.Based on these circumstances, unintentional user error (undue force) caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that insertion of a dialysis catheter by a physician intern and a senior physician: during insertion, it was impossible to advance the swg completely and to remove it from the needle.A new catheter has been inserted.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8700540
• MDR Text Key: 148055164
• Report Number: 3006425876-2019-00460
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K991431
• 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: 06/14/2019

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: 01/31/2024
• Device Catalogue Number: CV-12142-UF
• Device Lot Number: 71F19C2724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1