MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SCOREFLEX NC SCORING PTCA CATHETER; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	625-104-1U
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: report is manufacturer report number.
Event or Problem Description
It was reported a 2.5 x 10mm scoreflex nc scoring balloon was used for treatment of heavily calcified, moderately tortuous, 90% stenosed lesion in proximal to mid left anterior descending artery (lad) through femoral artery access.A non-abbott guide catheter and non-abbott guide wire were in use.Two inflations were performed.Following the second inflation at 20 atmospheres, the balloon burst.The rupture did not result in material separation; the scoreflex was fully removed.Flow-limiting dissection of the diagonal artery was suspected.Treatment of the dissection was attempted but the lesion could not be crossed with a non-abbott guide wire.The lad was stented and the diagonal artery was not treated.The patient was discharged from the hospital the following day as standard practice and the patient was stable on (b)(6) 2025.In the opinion of the physician, the scoreflex balloon possibly caused the dissection.No additional information was provided.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road; futian free trade zone; shang hai shi, shanghai 51803 8; CH 518038
• MDR Report Key: 22020352
• Report Number: 3004742232-2025-00137
• Device Sequence Number: 13114650
• Product Code: NWX
• UDI-Device Identifier: 06934955936340
• UDI-Public: (01)06934955936340(17)261121(10)3634552411
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025
• Report Date (Section F): 05/14/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 625-104-1U
• Device Catalogue Number: 625-104-1U
• Device Lot Number: 3634552411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/14/2025