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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD. JADE; JADE PTA BALLOON DILATATION CATHETER

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ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD. JADE; JADE PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number L540 50240
Device Problems Difficult to Remove (1528); Material Rupture (1546)
Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); Foreign Body In Patient (2687)
Event Date 05/20/2021
Event Type  Injury  
Event Description
The device will not be returned for investigation.Response letter is required.Event term: balloon damaged (remained in the body) treated lesion: sfa, 100% stenosed, h calcified, s tortuous.The physician performed pre-dilation of the lesion with the product, placed two eluvia 6.0x120 mm, and then performed post-dilation using the product again.Then the balloon was ruptured and got stuck in the stent placed.The physician was able to solve the stack and remove it from the stent by anterogradely inserting a guiding sheath and then crossing a small-diameter balloon beside the damaged product and expanding it.However, the physician was unable to retrieve the product which was removed from the stent into the guiding sheath, so that having the balloon pulled to the eia, he had no choice but placed the e-luminexx with sandwiching the product, therefore a part of the product remained in the body.Since then, the patient's condition has been stable.The physician commented about this event, "i'm not sure if the cause was a product defect.I want to know omkk's view on the causes regarding the balloon rupture and the stacking.".
 
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Brand Name
JADE
Type of Device
JADE PTA BALLOON DILATATION CATHETER
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, shenzhen 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 Key12906009
MDR Text Key286519816
Report Number3003775186-2021-04361
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K173894
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 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberL540 50240
Device Lot Number5300772101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/30/2021
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexFemale
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