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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOMETRICS, INC. FLOPPY-TIPPED NITINOL GUIDEWIRE,BOX OF 5
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NEOMETRICS, INC. FLOPPY-TIPPED NITINOL GUIDEWIRE,BOX OF 5 Back to Search Results
Model Number 50BX
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/14/2017
Event Type  malfunction  
Event Description
The guidewire was broken and the detached piece was unable to be removed from the kidney.
 
Manufacturer Narrative
This supplemental report is being submitted to provide results of dhr review and training record review, and to update the following sections: pma/510k,if follow-up, what type.The oem could not determine the cause of the event.No sample was returned for physical analysis.The dhr was reviewed and no relevant anomalies were found.The oem also reviewed operator training and manufacturing equipment records, and found no anomalies.The oem reported that this was the only broken guidewire complaint in an eight year period from june 2010 to july 2018, for a complaint rate of 0.01%.
 
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Brand Name
FLOPPY-TIPPED NITINOL GUIDEWIRE,BOX OF 5
Manufacturer (Section D)
NEOMETRICS, INC.
2605 fernbrook ln. n., ste. j
plymouth MN 55447
MDR Report Key6680842
MDR Text Key79145878
Report Number3005975494-2017-00002
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT-EYA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/06/2018
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 Model Number50BX
Device Lot NumberMO41024
Other Device ID Number00821925031487
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/15/2017
Initial Date FDA Received06/30/2017
Supplement Dates Manufacturer Received08/10/2018
Supplement Dates FDA Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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