MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	45881
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue with picc from a bio-stable picc (valved) 4f sl 55cm ir-145 kit with nitinol gw.The catheter was split approximately 1.5cm above the wing, therefore it was removed.The patient was put on orals so no replacement was performed.It was also reported that they use securacath and the nurses are educated not to use sharp objects around lines.This patient was quite challenging with behavior.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Received one (1) 4f single lumen picc.As received, the picc catheter was trimmed just past the 55cm mark.A "hole" was located at the "0 cm" marking, which is approximately 1.0cm from the proximal end of the suture wing.The "hole" is approximately 0.5cm long.There is a "bend/kink" at the 3cm mark as well.The customer's reported complaint description of hole in the catheter tubing was confirmed.The hole was created by slice damage from a sharp object like scalpel or scissors; not a kink or burst failure mode.The picc was in situ for 17 days so slice damage is not related to picc manufacturing or during the implant procedure.Slice damage likely occurred during dressing change, i.E.Damage to catheter tubing from scissors.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 dfu that is supplied with the bioflo picc device contains the following statements: intended use/indications for use: the bioflo picc with endexo and pasv valve technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.Warnings: do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.Precautions: carefully read all instructions prior to insertion, care or use.Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.Do not use sharp instruments near the extension tubes or catheter shaft.It is recommended that institutional protocols be considered for all aspects of catheter use consistent with the instructions provided herein.Do not use scissors to remove the dressing, as this may possibly cut or damage the catheter.Prior to dressing the catheter and access site, inspect both to assure that they are completely dry of isopropyl alcohol or acetone based cleansing agents.To avoid pooling of an agent, do not fully insert catheter up to suture wing.Do not attempt to repair the catheter.If breaks or leaks are apparent in the catheter, remove the catheter immediately patients must be educated regarding the care and maintenance of their picc.The healthcare provider is responsible for this patient instruction.Potential complications/adverse events: air embolism.Bleeding.Infection.Extravasation/infiltration of infusate.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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21631463
• Report Number: 1317056-2025-00046
• Device Sequence Number: 9309221
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 09/30/2026
• Device Model Number: 45881
• Device Lot Number: 5835066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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 Sex: Unknown