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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD MEDICAL DIVISION BARD DIAGNOSTIC WOVEN QUAD CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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BARD MEDICAL DIVISION BARD DIAGNOSTIC WOVEN QUAD CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pericardial Effusion (3271)
Event Date 08/22/2014
Event Type  Injury  
Event Description
This letter is to inform you of this adverse event as the suspect device (bard medical division -bard diagnostic woven quad catheter) is not manufactured or imported by biosense webster, inc.It was reported that the patient suffered a pericardial effusion.During the procedure the patient's pressure dropped and they became nauseous and complained of chest pain.The ics catheter confirmed a pericardial effusion and pericardiocentesis was performed.The patient is stable at this time and no further intervention is anticipated.The physician stated that the rv was perforated by the rv diagnostic catheter.The carto 3 system (11854), stockert 70 (st-0308), and coolflow pump (05047) were utilized in the procedure.The caller also stated that the ice catheter was from stryker, and the rv catheter was a bard diagnostic woven quad catheter.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
BARD DIAGNOSTIC WOVEN QUAD CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BARD MEDICAL DIVISION
MDR Report Key17528751
MDR Text Key321089585
Report NumberMW5135680
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/15/2014
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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