MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SAPPHIRE II PRO CORONARY DILATATION CATHETER; BALLOON DILATATION CATHETER

Model Number	230-153-5UU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Csi id: (b)(4).Related manufacturer (orbusneich) regulatory report: 3003775186-2024-00233.
Event or Problem Description
A diamondback 360 coronary orbital atherectomy device (oad) was used for treatment of severely calcified lesions in the circumflex (cfx) artery via femoral approach.The proximal ostial lesion was 70% stenosed and the mid distal lesion was 95% stenosed.The vessel diameter was 3.5mm.Several low-speed treatments were performed.Imaging was checked post atherectomy and the vessel looked fine.A 3.0 x 15mm sapphire ii pro sz balloon was advanced to the lesion and inflated three times.The first inflation was 12 atmospheres (atm) for fifteen seconds.The second inflation was 8 atm for ten seconds.The third inflation was 8 atm for twenty seconds.Following angioplasty, imaging was checked, and a perforation was observed.Covered-stent placement was performed to treat the perforation.A second stent was placed to cover the lesion.The patient was stable.In the opinion of the physician, the event was due to patient's anatomy.The patient was discharged home on (b)(6) 2024 after a planned overnight stay at the hospital unrelated to the reported perforation.

• Brand Name: SAPPHIRE II PRO CORONARY DILATATION CATHETER
• Common Device Name: BALLOON DILATATION CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• MDR Report Key: 19711734
• Report Number: 3004742232-2024-00254
• Device Sequence Number: 8920377
• Product Code: LOX
• UDI-Device Identifier: 06934955942334
• UDI-Public: 01069349559423341123101917251019104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/10/2024
• Report Date (Section F): 07/10/2024

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: 10/19/2025
• Device Model Number: 230-153-5UU
• Device Lot Number: 4212912310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2024
• Device Age: 34 WK
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White
• Date Report Sent to FDA: 07/10/2024