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

Model Number	10732201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a soft-vu of 5f x 65cm 035 nb 6sh.The radio-opaque distal tip of the catheter detached from the rest of the catheter during mid procedure.
Additional Manufacturer Narrative
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.Device history record review of the packaging/assembly shr lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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: 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: 20407413
• Report Number: 1319211-2024-00066
• Device Sequence Number: 17038896
• Product Code: DQO
• UDI-Device Identifier: H787107322010
• UDI-Public: H787107322010
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 10732201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG