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

Model Number	10732701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event 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 territory manager reported an end user experienced an issue when using a soft-vu kmp 5f x 65cm 038 nb 0sh.Customer was retracting out of vessel and not all of the catheter was there.The patient was sent to the hospital for further evaluation.Additional information: type of procedure: thrombectomy.No other tools- catheter was over a guide wire.No tortuous anatomy.There was a stent in the outflow tract.No resistance when passing anything in however it tore when pulled back.
Additional Manufacturer Narrative
Returned was one (1) angiographic catheter.The whole catheter wasn't returned, (distal portion of catheter/tip end was not returned).Per drawing 94940732701-us rev.A "usable length is to be 65cm +/- 2 cm, only 42.6cm was returned.The detachment location of the catheter is damaged.Based on feedback that the outflow tract had a stent and resistance/tearing when pulling catheter back was observed; handling damage to catheter during use is root cause.The customer's reported complaint description of "customer was retracting the catheter out of the vessel and not all of the catheter was there" was confirmed during evaluation of the returned complaint sample.Root cause of the catheter detachment was damage to the catheter shaft during device use.During pull back through the stent in the outflow tract the catheter became damaged and detached.A review of the device history records was performed for the reported packaging/assembly lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: instructions for use 16900444-01 is provided with this catheter device and contains the following statements.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.Warnings 1.Angiodynamics angiographic catheters should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.This includes interventional radiologists, vascular surgeons, interventional cardiologists and other physicians with a thorough understanding of angiography and percutaneous interventional procedures.2.Do not insert catheters directly through synthetic vascular grafts.Insert through a sheath introducer.3.Never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.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
• Common Device Name: 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: 20673339
• Report Number: 1319211-2024-00215
• Device Sequence Number: 18235229
• Product Code: DQO
• UDI-Device Identifier: H787107327010
• UDI-Public: H787107327010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 10732701
• Device Lot Number: A3024048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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