MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SOFT-VU; SOFT-VU ANGIOGRAPHIC CATHETER, OMNI FLUSH, NON-BRAIDED

Model Number	10732301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A territory manager reported an end user experienced an issue when using a soft-vu of 4f x 65cm 035 nb 6sh.They put the omni flush catheter over a.035 bentson wire with no issues into the abdominal aorta and power injected an aortogram.They then used a.035 standard angled glide wire to go over the aortic bifurcation into the sfa.There was a normal aortic bifurcation, no stents, stenosis or irregularity seen in the iliac systems.A lower extremity runoff was performed through the omni flush and identified sfa and pop disease.At this point a.035 abbott supracore was passed through the catheter into the sfa and the catheter was pulled back, when the tip of the catheter reached the aortic bifurcation there was some resistance.They pushed the catheter slightly forward again and it went easily, began to withdraw again and the tip of the catheter separated on the wire from the rest of the catheter.They pulled the catheter off and placed a 6fr 45cm terumo destination over the wire and telescoped the sheath off the dilator when they reached the broken tip and the tip went into the sheath still over the wire.They disconnected the sheath hub and slowly pulled the wire back until the tip was visualized and pulled off the wire.The patient had no complications from this event and the procedure was finished to completion.
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).
Additional Manufacturer Narrative
Corrections: d2a, e3: the customer's reported complaint description of angiographic catheter tip detached during the procedure could not be confirmed as no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Handling damage during device use is potential contributing factor since it was reported that resistance was encountered during catheter advancement.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 distribution performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: instructions for use 16900444-01 is provided with this catheter device and contains the following statements.Warranty: angiodynamics, inc.Warrants that reasonable care has been used in the design and manufacture of this instrument.This warranty is in lieu of and excludes all other representations and warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose.Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond angiodynamics, inc.'s control directly affect the instrument and the results obtained from its use.Angiodynamics, inc.'s obligation under this warranty is limited to the repair or replacement of this instrument and angiodynamics, inc.Shall not be liable for any incidental or consequential losses, damages or expenses directly or indirectly arising from the use of this instrument.Angiodynamics, inc.Neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument.Angiodynamics, inc.Assumes no liability with respect to instruments reused, reprocessed or resterilize, modified or altered in any way, and makes no warranties or representations, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.Contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your angiodynamics, inc.Representative.Inspect prior to use to verify that no damage has occurred in shipping.Do not use if package is damaged.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: SOFT-VU
• Common Device Name: SOFT-VU ANGIOGRAPHIC CATHETER, OMNI FLUSH, NON-BRAIDED
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 22461858
• Report Number: 1319211-2025-00031
• Device Sequence Number: 8550953
• Product Code: DQO
• UDI-Device Identifier: H787107323010
• UDI-Public: H787107323010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Model Number: 10732301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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