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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL CO. LTD JADE JADE PTA BALLOON DILATATION CATHETER

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ORBUSNEICH MEDICAL 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: ballon 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 (b)(4) view on the causes regarding the balloon rupture and the stacking. ".
 
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Brand NameJADE
Type of DeviceJADE PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
ORBUSNEICH MEDICAL CO. LTD
1 jinkui road,
futian free trade zone
shenzhen, shenzhen 51803 8
CH 518038
MDR Report Key12906006
MDR Text Key281508151
Report Number3014148220-2021-04361
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberL540 50240
Device Lot Number5300772101
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/29/2021
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: 11/30/2021 Patient Sequence Number: 1
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