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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 Problems Fracture (1260); Difficult to Remove (1528)
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 518038, shenzhen 518038 51803 8
CH 518038
Manufacturer (Section G)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
1 jinkui road
futian free trade zone
shenzhen, shenzhen 51803 8
CH 518038
Manufacturer Contact
samantha chan
1 jinkui road
futian free trade zone
shenzhen, shenzhen 51803-8
CH   518038
MDR Report Key11810739
MDR Text Key250201563
Report Number3003775186-2021-01711
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K180921
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Number203582002
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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