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

Model Number	210-103-5UU
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the sapphire balloon fractured, and the tip became stuck in the side cell of the left anterior descending (lad) stent into the diagonal.Multiple different wires and a non-csi/abbott catheter were used to dislodge the fractured fragment.As the fractured fragment was being retrieved, it fell off the wire in the aorta and became lost.In the physician's opinion, the embolization likely occurred in the patient's legs.To complete the procedure, a drug-eluting stent was placed in the left main artery.
Additional Manufacturer Narrative
Manufacturer regulatory report: 3003775186-2024-00111.Csi id: (b)(4).

• Brand Name: SAPPHIRE II PRO BALLOON DILATATION 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: 18921030
• Report Number: 3004742232-2024-00134
• Device Sequence Number: 6201913
• Product Code: LOX
• UDI-Device Identifier: 06934955942037
• UDI-Public: (01)06934955942037(11)231006(17)251006(10)4203462309
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/18/2024
• Report Date (Section F): 03/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: 210-103-5UU
• Device Catalogue Number: 7-10051-03
• Device Lot Number: 4203462309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/18/2024