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

Model Number	640-204-1U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135)
Date of Event	08/13/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer regulatory report: 3003775186-2024-00313.Csi id: (b)(4).
Event or Problem Description
The treated area was an 85% stenosed, heavily calcified distal to proximal left anterior descending (lad).Following the placement of an impella, the scoreflex balloon was advanced with the aid of a non-abbott guiding catheter.The scoreflex balloon was inflated twice to nominal pressure.Angiographic imaging was taken, and a perforation was observed.The exact location of the perforation in the lad could not be determined.The patient coded, and cardiopulmonary resuscitation (cpr) was performed, intubation and medication were administered.The patient stabilized, and three covered stents were placed to treat the perforation.The patient was transferred to intensive care unit (icu) for further observation.It was the physician's opinion the patient's heavy calcification caused the perforation; the calcium caused injury to the patient when the scoreflex balloon was inflated.Additional information received on 8/20/2024, the patient expired on (b)(6) 2024.In the opinion of the physician, although the perforation was the cause of death, the patient had highly calcified lesions.The rupture would have been caused by anything used to break that calcium.There was no allegation of deficiency or malfunction against the scoreflex balloon.

• 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: 20130364
• Report Number: 3004742232-2024-00319
• Device Sequence Number: 17991831
• Product Code: NWX
• UDI-Device Identifier: 06934955936487
• UDI-Public: (01)06934955936487(11)230708(17)250708(10)3619092306
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/03/2024
• Report Date (Section F): 08/23/2024

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: 07/08/2025
• Device Model Number: 640-204-1U
• Device Catalogue Number: 7-10082-24
• Device Lot Number: 3619092306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2024
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2024
• 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; Death; Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 08/23/2024