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

Catalog Number	210-103-5UU
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 and 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, embolization likely occurred in the patient's legs.To complete the procedure, a drug-eluting stent was placed in the left main artery.Patient status is satisfactory.The device history record for this lot: (4203462309) has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.No other similar complaints were received from the same lot of products up to now.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.

• Brand Name: SAPPHIRE II PRO BALLOON 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, shenzhen 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: 18919210
• Report Number: 3003775186-2024-00111
• Device Sequence Number: 14985153
• 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
• 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): 03/15/2024

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: 210-103-5UU
• Device Lot Number: 4203462309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/17/2024
• 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 Sex: Unknown