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

Model Number 625-104-1U

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

Patient Problem Vascular Dissection (3160)

Event Date 11/06/2023

Event Type  Injury  

Event Description

A score flex balloon was advanced over a guide wire and inflated slowly to 10 atmospheres (atm) for one minute, then slowly deflated.An angiogram was used to determine the balloon needed to be advanced three to five millimeters.The balloon was inflated slowly to 10 atmospheres for 30 seconds, and then slowly deflated.The physician attempted to remove the balloon, but the wire was coming back with the balloon.The balloon was unable to be removed without the wire, as it was wrapped around the balloon.Another angiogram was observed, and it was noticed there was a dissection on the diagonal.A non-csi wire was attempted to be used, but continued getting caught in the dissection.After multiple attempts, the physician was able to re-cross the diagonal with the balloon and a stent was placed in the lesion and dissection.

Manufacturer Narrative

Manufacturer regulatory report: 3003775186-2023-02286.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Type of Device: CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• MDR Report Key: 18231379
• MDR Text Key: 329318591
• Report Number: 3004742232-2023-00293
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 06934955936340
• UDI-Public: 01069349559363401122072817240728103618442207
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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
• Device Lot Number: 3618442207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2023
• Distributor Facility Aware Date: 11/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White