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

Catalog Number 10303819

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/02/2020

Event Type  malfunction  

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 Description

Event #2 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.

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 fo the reported complaint cannot be determined.Angiodynamics' supplier of this device was made aware of the event.Per the attached scar004120 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).

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 fo the reported complaint cannot be determined.Angiodynamics' supplier of this device was made aware of the event.Per the attached scar004120 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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• MDR Report Key: 10148790
• MDR Text Key: 198950641
• Report Number: 1317056-2020-00103
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103038191
• UDI-Public: H965103038191
• Combination Product (y/n): N
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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: 10303819
• Device Lot Number: 5561864
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1