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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. VSI BAND CLAMP, VASCULAR

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LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. VSI BAND CLAMP, VASCULAR Back to Search Results
Model Number 3524
Device Problem Air Leak (1008)
Patient Problem Hemostasis (1895)
Event Date 10/28/2016
Event Type  malfunction  
Manufacturer Narrative
Dhr was reviewed; testing has been performed on reserved samples and actual returned sample. However, root cause cannot be identified at present.
 
Event Description
After completing a radial access heart cath, the rt sheri applied the band and inflated the balloon to 17 mls. The patient was taken to the recovery floor and just prior to the first deflation, the balloon deflated completely causing a bleed. A new band was deployed and hemostasis was achieved.
 
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Brand NameVSI BAND
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
no.37, chaoqian road,
changping district
beijing, 10220 0
CH 102200
Manufacturer (Section G)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
no.37, chaoqian road,
changping district
beijing, 10220 0
CH 102200
Manufacturer Contact
bo jiang
no.37, chaoqian road
changping district
beijing, 10220-0
CH   102200
1381034605
MDR Report Key6408877
MDR Text Key70067021
Report Number3008002401-2017-00002
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2018
Device Model Number3524
Device Catalogue NumberN.A.
Device Lot Number201604015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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