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

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).

• 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 Key: 17528751
• MDR Text Key: 321089585
• Report Number: MW5135680
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 08/12/2023
• Patient Sequence Number: 1