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

Model Number 625-104-1U

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

Patient Problem Perforation of Vessels (2135)

Event Date 12/07/2022

Event Type  Death  

Event Description

A scoreflex balloon was used to treat a 99% stenosed severely calcified left anterior descending artery (lad).Following angioplasty, a stent was placed in the lesion.Imaging was performed and no anomalies were observed.A non-compliant balloon was used to post-dilate the stent three times.When contrast was injected, a perforation was observed where the stent was placed.Pericardiocentesis was performed, however, the patient passed away.The physician alleged the primary cause of death was due to severe calcification resulting in a minor dissection and perforation.

• Brand Name: CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Type of Device: SCOREFLEX NC SCORING PTCA CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• MDR Report Key: 15931722
• MDR Text Key: 304968086
• Report Number: 3004742232-2022-00307
• Device Sequence Number: 1
• Product Code: NWX
• 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: 12/07/2022

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: 625-104-1U
• Device Catalogue Number: 7-10082-10
• 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: 12/07/2022
• Distributor Facility Aware Date: 11/09/2022
• Event Location: Other
• Date Report to Manufacturer: 11/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 77 KG