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

Catalog Number	220-103-5UU
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Factors that could have contributed to this complaint may be related to the interaction between the balloon material and the calcified lesion, sharp object, interaction with other devices, patient anatomy, lesion calcification, or lesion tortuosity.A review of the manufacturing records for this lot (4201831801) did not reveal any non-conformities which could have contributed to the reported complaint.Based on the spc review, all individual burst result of lot 4201831801 were over rbp (rated burst pressure) which mean that the value of the burst testing was 23.1 atm and remaining stable, implying that the balloon forming process is in compliance with the product specification and in control.
Event or Problem Description
During an atherectomy procedure, the balloon was inserted into the proximal circumflex stenosis and inflated once.The balloon ruptured in the proximal branch, resulting in a retrograde dissection and slow flow into the left circumflex artery.A stent was deployed to resolve the dissection and the patient was in stable condition following the procedure.

• Brand Name: SAPPHIRE II PRO
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; shenzhen, guangdong 51803 8; CH 518038
• MDR Report Key: 7488184
• Report Number: 1064498-2018-00058
• Device Sequence Number: 2183046
• Product Code: LOX
• UDI-Device Identifier: 06934955942167
• UDI-Public: 6934955942167
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018
• Report Date (Section F): 04/19/2018

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: Physician
• Device Catalogue Number: 220-103-5UU
• Device Lot Number: 4201831801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2018
• 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