MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SCOREFLEX NC; SCOREFLEX NC SCORING PTCA CATHETER

Catalog Number 630-104-1U

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

Patient Problems Chest Pain (1776); Perforation (2001)

Event Date 07/25/2022

Event Type  Death  

Event Description

A scoreflex balloon was inflated three times in separate locations in a moderately calcified lesion in the mid left anterior descending (lad) artery.The patient experienced chest pain.Angiographic imaging was performed and revealed a perforation.A covered stent was placed, and balloon pump was inserted.The patient expired later that night.In the opinion of the physician, the balloon was the cause of the perforation of the lad, and the perforation was the cause of death.The balloon will not be returned.

• Brand Name: SCOREFLEX NC
• Type of Device: SCOREFLEX NC SCORING PTCA CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, shenzhen 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen guangdong, shenzhen guangdong 51803 8; CH 518038
• Manufacturer Contact: samantha chan ; no.1st jinkui road; futian free trade zone; shenzhen guangdong, shenzhen guangdong 51803-8 ; CH 518038
• MDR Report Key: 15161706
• MDR Text Key: 297207791
• Report Number: 3003775186-2022-02369
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P200041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/04/2022

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 Catalogue Number: 630-104-1U
• Device Lot Number: 3601282201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Female