MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number 10732203

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/28/2023

Event Type  malfunction  

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 Description

The soft-vu of 5f x 65cm 038 nb 6sh catheter was examined and was intact prior to use.During the procedure, the tip of the catheter broke off in the patient's blood vessel.The catheter tip was retrieved by the physician using a snare.The patient did not experience any adverse effects or harm due to this incident.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of angiographic catheter tip detached during procedure use could not be confirmed as no complaint sample was returned for evaluation and the customer did not provide any photos of the damaged product.Without receiving a sample for evaluation, a definitive root cause cannot be determined.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 review: instructions for use 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 SIZING ANGIOGRAPHIC CATHETER
• Type of Device: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• 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: 17565765
• MDR Text Key: 321530454
• Report Number: 1319211-2023-00044
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 10732203
• Device Lot Number: 5785472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1