MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SAPPHIRE II PRO CORONARY DILATATION CATHETER; Catheters, transluminal coronary angioplasty, percutaneous

Catalog 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
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.Background: lesion information: circumflex artery (proximal ostial lesion 70% and mid-distal lesion 95% stenosed, severely calcified).The vessel diameter was 3.5mm.Patient complication: vessel perforation.The balloon was 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.The patient was discharged home on (b)(6) 2024.In the opinion of the physician, the event was due to patient's anatomy.

• Brand Name: SAPPHIRE II PRO CORONARY DILATATION CATHETER
• Common Device Name: Catheters, transluminal coronary angioplasty, percutaneous
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; 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: 19612025
• Report Number: 3003775186-2024-00233
• Device Sequence Number: 6963209
• Product Code: LOX
• UDI-Device Identifier: 06934955942334
• UDI-Public: (01)06934955942334(11)231019(17)251019(10)4212912310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180921
• 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): 06/26/2024

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: 230-153-5UU
• Device Lot Number: 4212912310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG