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

Catalog Number 630-154-1U

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Heart Problem (4454)

Event Date 08/18/2022

Event Type  Death  

Event Description

Additional information received indicated the patient passed away due to organ failure.According to the physician, the patient death was unrelated to scoreflex.A scoreflex balloon was inflated twice at 14 atmospheres in the left anterior descending (lad) artery successfully.Afterwards, the balloon was repositioned to the left main (lm) coronary artery and ruptured at 16 atmospheres.Furthermore, dissection was noticed at the rupture site.The dissection was noted where wolverine was used in the ostium and body of lm.Balloon and stent angioplasty was performed to resolve the affected area.The patient was stable during and after the procedure.

• 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: 15434402
• MDR Text Key: 300022150
• Report Number: 3003775186-2022-02634
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 630-154-1U
• Device Lot Number: 3614212206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• 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