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

Model Number	630-204-1U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related manufacturer (orbusneich) regulatory report: 3003775186-2024-00192.Related importer (abbott) regulatory report:3004742232-2024-00192.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a mildly tortuous lesion in the right coronary artery (rca).The lesion was primarily wire with a non-csi/abbott guide wire.There was difficulty experiencing with the initial wiring.The guide wire was exchanged for a microcatheter.The viperwire advance guide wire was advanced to the rca without issue.Multiple low speed treatments were performed.The oad was removed after successful treatments.The viperwire was exchanged for a non-csi/abbott guide wire.Post dilation was performed using a scoreflex balloon and a non-csi/abbott balloon.Two drug-eluting stents were placed.After the procedure, review of angiographic imaging revealed a small perforation of the treated vessel.Intravascular ultrasound (ivus) did not detect a perforation during the procedure.No further medical intervention was needed, as the perforation was resolved during the procedure.The patient was hospitalized in stable condition.In the physician's opinion, the perforation was possibly related to the oad, although they suspected the non-csi/abbott devices also may have contributed.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: 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: 19351655
• Report Number: 3004742232-2024-00193
• Device Sequence Number: 20686141
• Product Code: NWX
• UDI-Device Identifier: 06934955936425
• UDI-Public: (01)06934955936425(11)230722(17)250722(10)3620832307
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2024
• Report Date (Section F): 05/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2025
• Device Model Number: 630-204-1U
• Device Catalogue Number: 7-10082-18
• Device Lot Number: 3620832307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2024