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

Catalog Number 10301203

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Hemorrhage/Bleeding (1888); Fibrosis (3167)

Event Date 01/27/2023

Event Type  Death  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A patient issue that occurred during a procedure in which a duraflow 2, 32cm straight basic kit was used.A patient was in for a dialysis catheter exchange (temp catheter to a perm catheter).A guidewire was inserted into a lumen of the original temp catheter to maintain access and the catheter was removed.Dilators from the duraflow 2 kit (item h787103012030) were used to dilate the vessel and the embosafe introducer sheath was then used.The first attempt to advance the embosafe dilator sheath was unsuccessful in advancing due to fibrotic tissue.There was no device malfunction, and it was reported the sheath was unable to be reused as it had become bent during the attempts to insert and advance.Another kit (item h787103012010) was opened so a new embosafe could be used.The second attempt was also unsuccessful, however, after the physician pulled it out, the sheath was "scrunched" up about halfway up the dilator.The physician determined there was a lot of fibrotic/scar tissue in the patient from previous access into the site.A teleflex dialysis kit was opened and a third attempt was made where there was still lots of resistance, but was successfully introduced.The physician removed the teleflex introducer (thinking this step must be done before tunneling the catheter to the insertion site) and some blood loss was experienced (exact amount unknown).The physician applied pressure to the site and stitched it up, where no further blood loss was experienced.No devices were inside the patient at the time of the cardiac arrest.The procedure was then aborted and a "code" was addressed shortly after.Chest compressions were performed, medications provided, and a blood transfusion was performed, however, the patient expired.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, customer provided a picture showing the sheath tubing was accordioned/buckled.The customer's reported complaint description of sheath tubing accordioned/buckled for confirmed based on picture provided by the customer.The event description and feedback from clinician clearly states that the difficulty to insert the sheath/dilator was due to a lot of fibrotic/scar tissue; i.E.Handling damage to device due to insertion into patient with tortuous anatomy.The likely root cause sheath issue is isolated incident of patient with tortuous anatomy.No conclusion can be made regarding the patient's expiration due to cardiac coding and the insertion attempts of the sheath/dilator given the information provided, however, this event has been captured in the post market surveillance of the duraflow dialysis catheter product family.The sheath/dilator accessory device is supplied to angiodynamics by manufacturer greatbatch medical.Scar004697 was sent to greatbatch medical for dhr review of the reported accessory device lots.Scar004697 states, "review of the manufacturing records did not reveal any discrepancies that would have contributed to this event.Root cause could not be determined and the rate of occurrence was within acceptable limits".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: the directions for use which is supplied to the end user with the reported catalog number contains the following statement: the valved peelable introducer sheath is not designed for use in the arterial system.The valved peelable introducer sheath is designed to reduce blood loss and the risk of air intake but it is not a hemostasis valve.The valve will substantially reduce air intake.At -12 mm hg vacuum pressure the valved peelable introducer sheath may allow up to 4cc/sec of air to pass through the valve.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 ; 5086587990
• MDR Report Key: 16303228
• MDR Text Key: 308833781
• Report Number: 1319211-2023-00007
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787103012031
• UDI-Public: H787103012031
• 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
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10301203
• Device Lot Number: 5768637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male