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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
Catalog Number 7-10084-80/
Device Problem Burst Container or Vessel (1074)
Patient Problems Pain (1994); Thrombosis/Thrombus (4440)
Event Date 09/03/2021
Event Type  malfunction  
Event Description
A jade otw angioplasty balloon was used during intervention on the right renal artery via left radial approach. An aortogram demonstrated an occluded right renal stent and calcifications to the left renal artery with no evidence of renal artery or parenchymal flow. Intervention was performed on the left renal artery, and a vessel injury there was identified and treated with a stent. The physician then cannulated the right iliac and chose to only perform angioplasty in that area in order to be minimally invasive following the prior vessel injury. The jade balloon was inflated in the common and external iliac arteries sequentially. Inflation was performed as planned in the external iliac artery. Thereafter, the balloon burst at nominal pressure (18atm) in the common iliac. The balloon was removed. However, the distal end of the balloon was captured within the stent. Several unsuccessful attempts were made to remove the distal fragment. Completion of angiogram demonstrated flow down the right common iliac artery. The patient had severe back pain at the end of the operation. The patient was transferred into recovery in stable condition but continued to experience back pain. The patient was admitted to the hospital for a thrombosis unrelated to the reported issue with the balloon. The patient was stable. The balloon had been inadvertently stored in a hot environment (90-99f) prior to use.
 
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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, CHN
CH CHN
Manufacturer (Section G)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
1 jinkui road
futian free trade zone
shenzhen 518038,, shenzhen 518038, CHN
CH CHN
Manufacturer Contact
samantha chan
1 jinkui road
futian free trade zone
shenzhen 518038,, shenzhen 518038, CHN
CH   CHN
MDR Report Key12531367
MDR Text Key274253214
Report Number3003775186-2021-03513
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 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number7-10084-80/
Device Lot Number5909972104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
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

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