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

Catalog Number	10303819
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
Event #1: an imaging supervisor reported that the tunneler sleeve component of this bioflo chronic dialysis catheter slid off the tunneler and become detached in the patient while tunneling was being performed.The sleeve was able to be removed after it was noticed to be missing from the tunneler.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was reported the defective disposable device is not available for return to the manufacturer.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The reported complaint description cannot be confirmed as there was no device to evaluate.The root cause for the reported complaint cannot be determined the tunneler is supplied to angiodynamics by the supplier martech.Scar004120 sent to the supplier, martech for dhr review of supplier lot.Per the response from martech medical, no pictures or samples were received by supplier.Production records were reviewed, quality records, and retained samples for production lot 061219-1.The same grade of material and colorant have been used for this part since 2005.The part is molded with all virgin material and the dimensional inspections are within the print tolerances.Retained samples from this lot were pressed flat and they did not crack.The process parameters are consistent and no changes have been done to the mold.Labeling review: directions for use is provided with this device and contains the following statement:: 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.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.Complaint reference (b)(4).

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• MDR Report Key: 10148787
• Report Number: 1317056-2020-00102
• Device Sequence Number: 2420639
• Product Code: MSD
• UDI-Device Identifier: H965103038191
• UDI-Public: H965103038191
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 07/31/2022
• Device Catalogue Number: 10303819
• Device Lot Number: 5561864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1