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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE II PRO

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ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE II PRO Back to Search Results
Catalog Number 210-153-5UU
Device Problem Fracture (1260)
Patient Problem Perforation (2001)
Event Date 04/28/2021
Event Type  Injury  
Event Description
The sapphire balloon fractured during use; the tip of the balloon was abandoned in vivo since it could not be removed from the diagonal branch. There was little to no flow in the vessel past the tip fragment. A perforation also occurred, but it is unknown if or how the balloon may have contributed to the perforation.
 
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Brand NameSAPPHIRE II PRO
Type of DeviceSAPPHIRE II PRO
Manufacturer (Section D)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
1 jinkui road
futian free trade zone
shenzhen, shenzhen 51803 8
CH 518038
MDR Report Key11810741
MDR Text Key250186472
Report Number3014148220-2021-01711
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number210-153-5UU
Device Lot Number4203582002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/01/2021
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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