MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 10302803

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reported defective 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

A customer risk manager reported an issue with a bioflo chronic dialysis catheter 15.5f 24cm dual valve sheath basic kit.The tunneled dialysis catheter sleeve became stuck on the catheter when the physician pulled it through the tunneled track, causing the sleeve to break off inside of the patient.The physician was able to retrieve the piece and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated the reported device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

The bioflo dialysis catheter assembly was returned with catheter tubing cut in half and tunneler sleeve attached to distal portion of the catheter tubing.The tunneler used during this procedure was not returned for evaluation.The distal end of the sleeve was damaged/split, which would allow the tunneler and catheter to be pulled through the sleeve.The customer's reported complaint description is confirmed.Although the complaint description is confirmed, a root cause for the event cannot be established.The tunneler sleeve accessory is supplied to angiodynamics by the supplier martech.Scar004238 was sent to martech for dhr review of affected supplier lot.As per scar004238 results from martech, the dhr review showed no issues with the production paperwork.The tri-ball tunneler accessory is supplied to angiodynamics by the supplier disposable instrument.Scar004227 sent to the supplier, disposable instrument for dhr review of supplier lot.As per scar004227 results from disposable instruments.The dhr review showed no issues with the production paperwork.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 following is provided as a reference from dfu: warning: do not over-expand subcutaneous tissue during tunneling.Over-expansion may delay/prevent cuff in-growth.6.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.Precaution: do not pull tunneler out at an angle.Keep tunneler straight to prevent damage to catheter tip.Note: a tunnel with a wide gentle arc lessens the risk of kinking.The tunnel should be short enough to keep the y-hub of the catheter from entering the exit site, yet long enough to keep the cuff 2 cm (minimum) from the skin opening.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: BIOFLO DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 10983756
• MDR Text Key: 220683964
• Report Number: 1317056-2020-00202
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103028031
• UDI-Public: H965103028031
• Combination Product (y/n): N
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 10302803
• Device Lot Number: 5567322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR