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

Model Number 3.0MM X 15MM

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 08/18/2022

Event Type  Injury  

Event Description

Balloon burst during inflation leading to a coronary dissection.Cardiovascular systems, inc.(b)(4).Fda safety report id# (b)(4).

• Brand Name: SCOREFLEX NC PTCA CATHETER NON-COMPLIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
• MDR Report Key: 15276334
• MDR Text Key: 298569639
• Report Number: MW5111654
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.0MM X 15MM
• Device Catalogue Number: 630-154-1U
• Device Lot Number: 3614212206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White