Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS VERRATA PLUS PRESSURE GUIDE WIRE; TRANSDUCER, PRESSURE, CATHETER TIP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS VERRATA PLUS PRESSURE GUIDE WIRE; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2019
Event Type  malfunction  
Event Description
The patient was brought to the cardiac catheterization laboratory.The patient was anticoagulated with a weight-based bolus of angiomax, followed by an infusion.The left anterior descending (lad) artery was approached with a 6 french 3.5 xb lad guiding catheter.A 0.014 verrata plus wire was zeroed outside the patient, then advanced with the transducer at the tip of the guiding catheter.At this point, the equipment indicated a "short." another wire was placed and demonstrated the same problems.The equipment was rebooted, and attempts made to bring it to a functioning status were unsuccessful.The procedure was then concluded, and angiomax infusion was terminated.The patient tolerated the procedure well and received hydralazine 10 mg iv, during the course of the case, for treatment of hypertension.The vendor was contacted and responded quickly.She replaced the defective wire and was available for several cases to be certain there were no further issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERRATA PLUS PRESSURE GUIDE WIRE
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
PHILIPS
9965 federal dr.
colorado springs CO 80920
MDR Report Key9990277
MDR Text Key188658964
Report Number9990277
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2020
Event Location Hospital
Date Report to Manufacturer04/23/2020
Type of Device Usage N
Patient Sequence Number1
Patient Age31755 DA
-
-