MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	10714004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
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 cardiologist reported an issue with a soft-vu of 4f x 90cm 038 nb 6sh.During a procedure, the catheter was advanced and hit calcification, resulting in the tip of catheter breaking off, into the patient.The tip was recovered immediately and patient did not require further intervention.Ultimately, the procedure was completed with another same device and the patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
Received one (1) soft-vu catheter with tip detached and included.As received, the tip is separated and ends appear to be a pull/peel break failure mode.The customer's reported complaint description of the catheter tip detached was confirmed.The fracture location was approximately 1 cm distal from the junction between the catheter shaft and the tip tubing and there is no indication that the tip tubing material is brittle, i.E.Tubing is soft and pliable and fracture of tubing looks to be a result of handling damage - pulled/stretched tubing failure mode.The root cause of the tip detachment cannot be definitively determined but likely root cause is handling damage during use, specifically, advancement against calcification.The dfu warns: "never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both." engineer evaluation: the catheter was received with the tip fractured and detached.Fracture was at distal tip, approximately 43mm from the end of the catheter.The fractured piece appears to be damaged at the distal tip opening.There is a 100% in-process inspection for tip damage that would have captured the damage.The tip appears to have been stretched to the point of failure.There are no obvious signs of additional damage along the entire length of the catheter.Dhr review does not show any ncrs written against this job.The root cause of the tip fracture is unknown, possibly indicating that handling damage is a potential contributing factor.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 reviewing: directions for use that is provided with the angiographic catheter device and contains the following statements: indications: angiodynamics* angiographic catheters are for use where angiographic diagnosis is indicated.Warnings: never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Do not attempt to hand straighten the tip of any curved tipped catheters which are furnished with a tip straightener.Hand straightening may result in damage to the product.Tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.Reshaping of the catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat.Do not leave curved tipped catheters straightened over guidewires for extended periods of time.This will result in failure of the catheter tip to re-form to its intended shape.When retracting catheters, great care must be taken to avoid exerting excessive pressure at the groin entry site.Excessive pressure may result in damage to the vessel, the catheter, or both.Potential adverse effects the following adverse reactions have been reported and are associated with the use of angiographic catheters: thrombus formation, emboli, arterial wall damage, plaque dislodgment, hematoma, cardiac arrhythmias, myocardial infarction, stroke, death.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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21228615
• Report Number: 1319211-2025-00001
• Device Sequence Number: 8341502
• Product Code: DQO
• UDI-Device Identifier: H787107140040
• UDI-Public: H787107140040
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 10714004
• Device Lot Number: 5832613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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