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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD JADE JADE OTW

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ORBUSNEICH MEDICAL (SHENZHEN) 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.
 
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Brand NameJADE
Type of DeviceJADE OTW
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 518038, shenzhen 518038 51803 8
CH 518038
Manufacturer Contact
samantha chan
1 jinkui road
futian free trade zone
shenzhen 518038, shenzhen 518038 51803-8
CH   518038
MDR Report Key12757294
MDR Text Key280457116
Report Number3003775186-2021-04135
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K202231
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 11/05/2021
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
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? No
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: 11/07/2021 Patient Sequence Number: 1
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