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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER
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VOLCANO CORPORATION VERRATA PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 10185
Device Problems Disconnection (1171); Misconnection (1399); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2016
Event Type  malfunction  
Event Description
The verrata pressure wire package was opened.The connector was already unplugged from the wire.It would not register with the volcano.It just kept saying to attach the connector.The scrub attempted to attach the connector multiple times but it would not work.We had to open a new one, which worked just fine.We feel it was possibly faulty prior to being removed from the package because the wire was disconnected from the connector, which is very unusual.In the past, we do not recall the wire being disconnected prior to removing the device from the packaging.No patient harm.Documented 5 minute delay.Device is still in our possession but we will give it to the rep.
 
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Brand Name
VERRATA PRESSURE GUIDE WIRE
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova CA 95670
MDR Report Key6084931
MDR Text Key59405540
Report Number6084931
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2016
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/31/2019
Device Model Number10185
Other Device ID Number185 CM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2016
Event Location Hospital
Date Report to Manufacturer11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; YES, BUT UNKNOWN.ANGIOPLASTY/STENT.
Patient Age70 YR
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