MAUDE Adverse Event Report: ANGIODYNAMICS DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	10301219
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a duraflow dialysis catheter.During procedure closure, the tunneler sheath [sleeve] broke off into a patient.The sheath was successfully removed with no patient impact.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was one duramax dialysis catheter with tunneler and tunneler sleeve.The tunneler sleeve was observed to have slight digs/scratches along with stretching.The tunneler shows no noted defects.As received, the catheter, tunneler and tunneler sleeve were separate from each other.The tunneler has a significant bend in the center from use.The tunneler sleeve has marks, as if gripped with a serrated tool such as hemostats, near the tip and near the transition from the large od to the tapered section of the sleeve.The tip appears slightly stretched and there is some slight deformation near the transition from the large od to the tapered section of the sleeve.Based on similar reported complaints for tunneler 10006108 pulling through/detaching from the tunneler sleeve (10006082), the potential root cause of this issue is tunneler od dimensions (tapered section) where it mates with tunneler sleeve.No returned tunneler samples have been observed to be out of specification for the od dimensions.The damaged condition of the returned tunneler sleeves has prevented id dimensions from being taken.The use and performance of the tunneler with sleeve is also dependent on end user technique, e.G.Size of tunnel incision and force applied.The customer's reported complaint description was confirmed for sleeve pulling off/detaching from tunneler.Although a sample was returned, a definitive root cause for this event could not be determined.The tunneler and tunneler sleeve met dimensional specifications with the exception of the tunneler sleeve id.The id was likely stretched during the process of being pulled off the tunneler.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use, supplied to the end user: "use blunt dissection to create the subcutaneous tunnel opening.Attach the catheter to the trocar (a slight twisting motion may be helpful).Slide catheter tunneling sleeve over the catheter making certain that the sleeve covers the distal tip of the catheter.Insert the trocar into the exit site and create a short subcutaneous tunnel.Do not tunnel through muscle.The tunnel should be made with care in order to prevent damage to surrounding vessels.Warning: do not over-expand subcutaneous tissue during tunneling.Over-expansion may delay/prevent cuff in-growth.Lead catheter into the tunnel gently.Do not pull or tug the catheter tubing.If resistance is encountered, further blunt dissection may facilitate insertion.Remove the catheter from the trocar with a slight twisting motion to avoid damage to the catheter.Caution: do not pull tunneler out at an angle.Keep tunneler straight to prevent damage to catheter tip." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference: (b)(4).

• Brand Name: DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11968679
• Report Number: 1319211-2021-00046
• Device Sequence Number: 19900705
• Product Code: MSD
• UDI-Device Identifier: H787103012195
• UDI-Public: H787103012195
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 10301219
• Device Lot Number: 5666921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1