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

Model Number	640-104-1U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A heavily calcified proximal left anterior descending artery (lad) was the target treatment area.Following shockwave intravascular lithotripsy (ivl) and stent placement a trek nc balloon was advanced for post dilation then the scoreflex balloon was advanced, with the aid of a non-csi or abbott guide wire, and inflated to 12 atmosphere pressure (atm) and removed.Optical coherence tomography (oct) and angiography was checked and a perforation was observed.Angioplasty was performed using new trek balloon to treat the perforation but was unsuccessful.Ecmo and impella were performed and a new non-csi or abbott guide wire was advanced and a stent was placed to treat the perforation.The patient was stable and transferred to a different facility for bypass surgery.The physician's opinion was the patient's heavily calcified artery was a fracture as to why the perforation occurred but could not say which one device caused or contributed to the perforation.It was noted that the vessel was not prepped properly by using an oversized stent.
Additional Manufacturer Narrative
Manufacturer regulatory report: 3003775186-2024-00099.Csi id: (b)(4).

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): ORBUSHNEICH MEDICAL CO., LTD.; no. 1 jinkui road; futian free trade zone; shenzhen 51803 8; CH 518038
• MDR Report Key: 18865543
• Report Number: 3004742232-2024-00114
• Device Sequence Number: 3306249
• Product Code: LOX
• UDI-Device Identifier: 06934955936463
• UDI-Public: (01)06934955936463(11)230412(17)250412(10)3610862304
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/13/2024
• Report Date (Section F): 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2025
• Device Model Number: 640-104-1U
• Device Catalogue Number: 7-10082-22
• Device Lot Number: 3610862304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/12/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 03/08/2024