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

Catalog Number	630-204-1U
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
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 and scoreflex balloon, although they suspected the non-csi/abbott devices also may have contributed.Background: there were patient complications: perforation.Patient status: satisfactory.Treated lesion information: mildly tortuous, rca.No returned device/image/cd was provided for analysis.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; no.1st jinkui road; 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: yuki li ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 19307703
• Report Number: 3003775186-2024-00192
• Device Sequence Number: 20660511
• 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
• PMA/510(K) Number: P200041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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 Catalogue Number: 630-204-1U
• Device Lot Number: 3620832307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown