• 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. JADE JDAE PTA

  • 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. JADE JDAE PTA Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 09/30/2021
Event Type  Injury  
Event Description
A perforation occurred in the anterior tibial artery during use of the jade balloon. The event occurred in late september or early december. The csi field rep stated they submitted the complaint. However, there is no record of the submission. At this time, given the interval since the event happened, additional information is not available from the facility per the csi sales rep. The patient was stable following the procedure. The device was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJADE
Type of DeviceJDAE PTA
Manufacturer (Section D)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
no.1st jinkui road
futian free trade zone
shenzhen, shenzhen SHENZ HEN
CH SHENZHEN
Manufacturer (Section G)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD
no.1st jinkui road
futian free trade zone
shenzhen guangdong, shenzhen guangdong 51803 8
CH 518038
Manufacturer Contact
samantha chan
no.1st jinkui road
futian free trade zone
shenzhen guangdong, shenzhen guangdong 51803-8
CH   518038
MDR Report Key13702172
MDR Text Key287189245
Report Number3003775186-2022-00771
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
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 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/05/2022
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: 03/09/2022 Patient Sequence Number: 1
-
-