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

Model Number 635-154-1U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 04/24/2023

Event Type  Injury  

Event Description

The scoreflex balloon was used for treatment in the mid left anterior descending artery (lad), in stent restenosis (isr).Intravascular ultrasound showed the vessel was 4.2 mm.The scoreflex balloon was advanced, with the aid of a non-csi guide wire, and inflated to 20 atmosphere pressure (atm).A perforation occurred.The perforation was treated with a covered stent and pericardiocentesis was performed with minimal blood loss.Flow to the lad was sufficient.Patient was stable.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Type of Device: CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): ORBUSHNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road; futian free trade zone; shenzen, 51803 8; CH 518038
• MDR Report Key: 16989186
• MDR Text Key: 315833737
• Report Number: 3004742232-2023-00145
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

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
• Device Operator: Health Professional
• Device Model Number: 635-154-1U
• Device Lot Number: 3631892210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Distributor Facility Aware Date: 04/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White