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

Catalog Number 10301202

Device Problem Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An or manager reported an issue with a duraflow 2, 28cm straight basic kit.During a laparoscopic peritoneal dialysis catheter insertion procedure, the surgeon attempted to pull the guidewire out of the vessel and was met with resistance due to a kink.When the guidewire was pulled out, it became unravelled and a piece fell off inside of the patient.The surgeon was able to remove the fragment from the patient and the procedure was completed with a new kit.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.To note, the surgeon was later informed by an angiodynamics rep that this device is for hemodialysis use only, not peritoneal dialysis.

Manufacturer Narrative

Returned for evaluation was one guidewire.As received, the guidewire was returned in multiple pieces.Scar004503 and the guidewire complaint sample were sent to supplier, lake region for sample evaluation/root cause determination and dhr review of supplier lot {6204382}.P the scar004503 response from lake region, since there was no evidence that this failure mode can be caused by improper manufacture of this product, there are no reasons to think this is a manufacturer-related issue.However it was noted "there was evidence of necking at the fracture point, this indicate that the fracture was caused by tensile overload".Lake region stated the dhr review demonstrated compliance and conformance to applicable procedures and specifications; no manufacturing non-conformance was observed.A definitive root cause for this event could not be determined, however, use of the device as a peritoneal dialysis catheter insertion may be a contributing factor.In addition, the duraflow dialysis catheter device is intended for hemodialysis treatment via ij, subclavian or femoral vein insertion/access.This device is not indicated for peritoneal dialysis catheter insertion and the use of this device in this manner may have contributed to the guidewire detachment event.The customer's reported complaint description of guidewire fractured and detached was confirmed.Although the reported complaint description is confoirmed, a defintive root cause cannot be determined.The most likely root cause is use of the device as a peritoneal dialysis catheter insertion a review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: directions for use is provided with this device and contains the following statements: indications for use: the duraflowtm 2 hemodialysis catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis.It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.Alternate insertion sites include subclavian vein as required.Catheters greater than 40 cm are intended for femoral vein insertion.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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13385468
• MDR Text Key: 286673808
• Report Number: 1319211-2022-00002
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787103012025
• UDI-Public: H787103012025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• 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: 10301202
• Device Lot Number: 5681199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 213 KG
• Patient Ethnicity: Hispanic