MAUDE Adverse Event Report: NATEC MEDICAL LTD VICTORY HP PTA OTW 0.035" CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	VAHH0710_00-40S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record confirmed that the lot met all applicable manufacturing and release specifications.The device was not returned for evaluation; however, customer-provided photographs verified the reported distal balloon tear.No patient complications were associated with this event.A follow-up report will be submitted if any additional information become available.Review of manufacturing records did not identify any manufacturing-related contributory factors.Due to the absence of the returned device and limited clinical details, the exact cause of the balloon tear and distal shaft detachment could not be determined.
Event or Problem Description
Client reported broken catheter failure from one of their dialysis access center.The issue was during a dialysis procedure; they used one of the victory hp 10x40 balloons.This was a recent hp balloon that actually had a transverse tear and when attempting to remove it from the patient through the sheath, the distal catheter shaft and distal portion of the balloon detached.They were able to retrieve both portions.No patient issues.Victory hp pta balloon dilatation catheter, lot# c67834, balloon size: 10.00 x 40mm, quantity - 01 unit.

• Brand Name: VICTORY HP PTA OTW 0.035" CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section G): NATEC MEDICAL LTD; ava technopark, medtech road,; cote d'or technopole, minissy; moka, 80829 ; MP 80829
• Manufacturer Contact: roy pallippatt ; ava technopark, medtech road,; cote d'or technopole, minissy,; moka, 80829 ; MP 80829
• MDR Report Key: 24160182
• Report Number: 3004415014-2025-00001
• Device Sequence Number: 9029335
• Product Code: LIT
• UDI-Device Identifier: 06091403561933
• UDI-Public: 06091403561933
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K220410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: VAHH0710_00-40S
• Device Lot Number: C67834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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