MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO; BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY - 4F X 55CM CATHETER MST-70 KI

Model Number	45891
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/06/2025
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
Spectrum reported an end user experienced an issue bio-stable 4f sl 55cm mst-70 kit valved with nitinol guidewire.It was reported that over several days after the patient's picc was placed, when the patient was attached to continuous infusion, the patient's lower arm swells.With basic manual flush of 10-20ml of saline the swelling is not noted.It only occurs during the continuous infusion.An x-ray was performed on the arm and chest.The tip of the catheter was in the svc, however, there was a kink observed approximately 5-6cm above the insertion site.The picc was removed and replaced.Upon removal, a curve in the picc was noted at the 4-6cm mark.
Additional Manufacturer Narrative
The customer's reported complaint of picc catheter tubing became kinked during in situ use was not confirmed during evaluation of the returned picc complaint sample, however, there was a curve to the catheter tubing at approximately the 4cm mark.No manufacturing non-conformance was observed and catheter tubing met dimensional specification.The picc device was in situ for 7 days and infusion was only difficult when patient was attached to continuous infusion (i.E.Pump).No issue observed with manual infusion, confirming that the catheter lumen was not occluded.Likely root cause for the curve in the catheter tubing during in situ use is patient anatomy.No product non-conformance was observed.Device history record review of the packaging/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/picc assembly lots for similar catheter kinked issue (out of box or in situ).Labeling review: as noted during the review of the directions for use (dfu) item number 14655753-01 that is supplied in the reported kit, the following precautions/warnings are stated: 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.Potential complications/adverse events: catheter rupture, extravasation of infusate.Management of lumen occlusion: provided there is no resistance with aspiration, flush the catheter vigorously with sterile normal saline to try to move the tip away from the vessel wall.Use a 10 ml or larger syringe.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis.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: BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY - 4F X 55CM CATHETER MST-70 KI
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: ashleigh garcia ; 10 glens falls technical park; suite 1000; glens falls, NY 12801 ; 8134543296
• MDR Report Key: 23728733
• Report Number: 1317056-2025-00330
• Device Sequence Number: 9071906
• Product Code: LJS
• UDI-Device Identifier: H965458910
• UDI-Public: H965458910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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 Model Number: 45891
• Device Lot Number: 5852677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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