• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problem Perforation (2001)
Event Date 05/12/2021
Event Type  Injury  
Event Description
There was difficulty advancing devices across a lesion. An orbusneich sapphire balloon was used to perform angioplasty. When the balloon was inflated, a perforation occurred. The balloon was reported to have been discarded and is not available for return. Additional information has been requested but has not yet been received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSAPPHIRE
Type of DeviceSAPPHIRE
Manufacturer (Section D)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
no.1st jinkui road
futian free trade zone
shenzhen guangdong,, shenzhen guangdong, CN 51 8038
CH CN 518038
MDR Report Key11926431
MDR Text Key253968345
Report Number3014148220-2021-01792
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 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/14/2021
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: 06/02/2021 Patient Sequence Number: 1
-
-