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

Catalog Number	10303804
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
An end user reported an issue with a bioflo duramax 15.5f 28cm single valve sheath basic kit.During a planned exchange procedure, because the catheter had not been functioning properly, the catheter was removed and found to be bulging at the proximal end.The device was replaced with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.
Additional Manufacturer Narrative
Returned for evaluation was one (1) 28cm bioflo duramax dialysis catheter.As received, approximately the first three cm of catheter tubing distal to the bifurcate suture wing is bulging.The rest of the catheter is normal in appearance.The catheter was sectioned in the area of the bulge and it shows that both lumens have become misshapen and oversized.The venous lumen (blue clamp side) of the catheter is larger than the arterial lumen (red clamp side).The customer's complaint description of bulging catheter is confirmed.Approximately the first three cm of catheter tubing distal to the bifurcate hub is bulging.The catheter was sectioned distal to the bulge and was confirmed to meet dimensional specifications.No manufacturing non-conformance were observed.A definitive root cause could not be determined from the sample review; however, the bulge in the tubing is most likely due to over-pressurization.The customer reported that the dialysis catheter was being removed due to the device no longer functioning properly.A potential root cause for this event is an occluded catheter that caused over-pressurization in the lumens that caused the tubing to bulge.The dialysis catheter was in use for more than 6-months, therefore, this was not a performance issue of the device shortly after implant, but later due to care and maintenance.Labeling review: the following is provided as a reference from dfu: warning contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping.For single patient use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Warning: only a physician familiar with the appropriate techniques should attempt the following procedures.Insufficient flows: the following may cause insufficient blood flows: · occluded arterial hole due to clotting or fibrin sheath.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
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15412717
• Report Number: 1317056-2022-00114
• Device Sequence Number: 5512275
• Product Code: MSD
• UDI-Device Identifier: H965103038041
• UDI-Public: H965103038041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: 01/31/2024
• Device Catalogue Number: 10303804
• Device Lot Number: 5686309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female