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

Model Number	45891
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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
A distributor reported an end user experienced an issue with a picc from a bio-stable 4f sl 55cm mst-70 kit valved with nitinol guidewire.The patient had their bioflo picc inserted for home parenteral nutrition (pn) on (b)(6) 2024.As reported to msa, there has been a "breakage of white section of extension tubing" on a bioflo picc that was originally implanted in (b)(6) 2024, for home parenteral nutrition (pn) purposes.The "]crack' was noticed by the patient's mother on (b)(6) 2025, when she had unhooked the pn and saw a drop of blood on the sheet.The picc was removed the same day, (b)(6) 2025.[dwell time: 124 days] the patient has had a new bioflo picc implanted on (b)(6) 2025, to continue intravenous therapy (ivt) and daily blood sampling.When asked for the current status of the patient following the event, the nurse responded: "presentation to emergency department.Pivc insertion (previous difficult and traumatic pivc insertions so the idea of this was particularly distressing to the patient and family).No nutrition until new picc inserted (had iv fluids to maintain hydration).".
Additional Manufacturer Narrative
Received one (1) 4f sl picc for evaluation.The customer's complaint description of extension leg leak was confirmed during sample review as there is a fracture hole in the extension leg tubing adjacent to the oversleeve junction.No oversleeve molding or other manufacturing non-conformances were observed.Root cause could not be definitively determined but handling damage during device use (e.G.Dressing changes - aggressive torque bending during cleaning and/or damage from scissors) is potential contributing factor.Device history review of the packaging/assembly/ oversleeve sub-assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/assembly/oversleeve sub-assembly lots for similar extension leg fractured/hole issue.Labeling review: directions for use (dfu) that is supplied with this device contains the following statements: warnings: do not use if package is opened or damaged.Do not fully insert catheter up to suture wing.Do not use sharp objects to open package as damage to the device may occur.If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair: in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.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 ; 8007726446
• MDR Report Key: 21977275
• Report Number: 1317056-2025-00119
• Device Sequence Number: 9274599
• Product Code: LJS
• UDI-Device Identifier: H965458910
• UDI-Public: H965458910
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 04/30/2026
• Device Model Number: 45891
• Device Lot Number: 5823653
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 45 KG