MAUDE Adverse Event Report: SURMODICS, INC. SURVEIL DCB; Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Model Number	SRV03513504015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Analysis confirmed complete radial tear on proximal end.The investigation could not confirm whether the balloon tear was caused by the closure device or balloon burst.
Event or Problem Description
A 4.0mm x 150mm x 135cm surveil drug-coated balloon (lot w240003) was used to treat a lesion in the common femoral artery of a 58-year-old female patient with a relevant history of dialysis, hypertension, peripheral artery disease, coronary artery disease, hypercholesterolemia, and diabetes.During the procedure, a non-abbott closure device was present proximally in the anatomy.The surveil balloon was advanced to the target lesion and inflated as intended.Upon inflation, a loss of pressure was noted and balloon rupture was suspected.There was resistance encountered with the closure device during removal; the balloon was pulled away from the device but did not detach, and the entire device was removed from the anatomy as a single unit.There were no adverse patient effects and no clinically significant procedural delay.The procedure was completed at that point.No additional clinical consequences were reported.

• Brand Name: SURVEIL DCB
• Common Device Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Manufacturer (Section D): SURMODICS, INC.; 9924 west 74th street; eden prairie MN 55344
• Manufacturer Contact: peter bather ; 9924 west 74th street; eden prairie, MN 55344 ; 9525007548
• MDR Report Key: 23595544
• Report Number: 3001374820-2025-00002
• Device Sequence Number: 9336903
• Product Code: ONU
• UDI-Device Identifier: 00812339030388
• UDI-Public: 00812339030388
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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 Expiration Date: 01/31/2026
• Device Model Number: SRV03513504015
• Device Lot Number: W240003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Asian