MAUDE Adverse Event Report: BARD DYNAMIC DECAPOLAR CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Malposition of Device (2616)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208); Diaphoresis (2452); Pericardial Effusion (3271)

Event Date 10/06/2016

Event Type  Injury  

Event Description

It was reported that after the pvc ablation the patient presented diaphoretic and their pressure starting dropping.The physician used the soundstar catheter to evaluate for an effusion.A pericardial effusion was seen on us.The patient was stable at the time of the call and the physician was still deciding on further treatment.The case was complete when the effusion was found.The ablation catheter was st df #d132705.Additional information was received on 10/11/2016; physician's opinion regarding the cause of the adverse event was that it was procedure-related.Physician believes the injury was a result of advancing the webster cs catheter too far into the coronary sinus, resulting in the rupture of the distal portion of the coronary sinus.Therefore, this event was reported to the fda under the bwi webster cs catheter (mdr report# 2029046-2016-00240) additional information was later received on 11/09/2016: webster decapolar was not used during this case.Bard dynamic decapolar was used.The catheter and the box was disposed of after the case.No additional information is available.Per this information the bwi catheter was not used and therefore this event is not reportable to bwi.The suspected device is the bard dynamic decapolar catheter.Pi1-157rxu5.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DYNAMIC DECAPOLAR CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BARD
• MDR Report Key: 17524637
• MDR Text Key: 321140445
• Report Number: MW5131583
• 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: 11/29/2016

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