MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SCOREFLEX NC SCORING PTCA CATHETER; Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Catalog Number 630-154-1U

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

This adverse event was reported in esg test system on (b)(6) 2023 (mfr report #: 3003775186-2023-01623).Since we realize it is not correct to report it in the test system, we now take the corrective action to submit this report in the production system.This adverse event is an individual case and per our investigation, it is concluded that there is no evidence of a product malfunction, inadequacy in the ifu, or a manufacturing defect regarding this event.We have taken corrective and preventive actions in our company to correct the wrong reporting issue and prevent this issue from re-occurring in the future.

Event Description

The scoreflex balloon burst at 14 atmospheres (atms) causing an antegrade dissection.A stent was placed to complete the procedure.The patient was in stable condition.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Type of Device: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: air xu ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 18947224
• MDR Text Key: 338185774
• Report Number: 3003775186-2023-01623
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 3641292212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• 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): Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 95 KG