• 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 CO. LTD JADE JADE OTW

  • 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 CO. LTD JADE JADE OTW Back to Search Results
Lot Number 5900522101
Device Problems Stretched (1601); Patient-Device Incompatibility (2682)
Patient Problem Vascular Dissection (3160)
Event Date 10/20/2021
Event Type  Injury  
Event Description
A jade balloon was used in the left superficial femoral artery (sfa) via contralateral access with a 6fr sheath. Laser atherectomy was used prior for a neointimal hyperplasia in stent restenosis. The 6. 0mm jade balloon was applied post laser treatment. The balloon marker was placed at the distal end of the 6. 0mm stent. When the balloon was inflated, it elongated outside of the stent. The physician opinion is that this led to a dissection in the popliteal artery. A 4. 0mm jade balloon long inflation to try and resolve the dissection. (there was also a complaint related to this balloon. See csi complaint (b)(4)to follow). A second stent was placed in the popliteal. The balloon will be returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJADE
Type of DeviceJADE OTW
Manufacturer (Section D)
ORBUSNEICH MEDICAL CO. LTD
1 jinkui road
futian free trade zone
shenzhen 518038, shenzhen 518038 51803 8
CH 518038
MDR Report Key12757446
MDR Text Key285044243
Report Number3014148220-2021-04135
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 Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number5900522101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/28/2021
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
-
-