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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SDN. BHD. INLAY OPTIMA STENT
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BARD SDN. BHD. INLAY OPTIMA STENT Back to Search Results
Lot Number MYYITA09
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/07/2014
Event Type  malfunction  
Event Description
It was reported that the device was placed in a pt with hydronephrosis and infection.After the placement procedure, the doctor found the tiger tail flex tip to be missing.An x-ray check revealed the tip to be left in the kidney pelvis.X-ray images taken just after placement of the tiger tail catheter also showed the tip was detached.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be mailed.
 
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Brand Name
INLAY OPTIMA STENT
Manufacturer (Section D)
BARD SDN. BHD.
kulim, kedah
MY 
Manufacturer (Section G)
BARD SDN. BHD.
lot 57c kulim industrial estate
kulim, kedah 0900 0
MY   09000
Manufacturer Contact
christy lewis
8195 industrial blvd.
covington, GA 30014
7707846100
MDR Report Key4377285
MDR Text Key17229639
Report Number1018233-2014-00364
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberMYYITA09
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/23/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2014
Initial Date FDA Received12/23/2014
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 Sequence Number1
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