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

Model Number	625-104-1U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A score flex balloon was advanced over a guide wire and inflated slowly to 10 atmospheres (atm) for one minute, then slowly deflated.An angiogram was used to determine the balloon needed to be advanced three to five millimeters.The balloon was inflated slowly to 10 atmospheres for 30 seconds, and then slowly deflated.The physician attempted to remove the balloon, but the wire was coming back with the balloon.The balloon was unable to be removed without the wire, as it was wrapped around the balloon.Another angiogram was observed, and it was noticed there was a dissection on the diagonal.A non-csi wire was attempted to be used, but continued getting caught in the dissection.After multiple attempts, the physician was able to re-cross the diagonal with the balloon and a stent was placed in the lesion and dissection.
Additional Manufacturer Narrative
Manufacturer regulatory report: 3003775186-2023-02286.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• MDR Report Key: 18231379
• Report Number: 3004742232-2023-00293
• Device Sequence Number: 17692932
• Product Code: NWX
• UDI-Device Identifier: 06934955936340
• UDI-Public: 01069349559363401122072817240728103618442207
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/29/2023
• Report Date (Section F): 11/29/2023

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: 07/28/2024
• Device Model Number: 625-104-1U
• Device Catalogue Number: 7-10082-10
• Device Lot Number: 3618442207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 11/29/2023