MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER COMPLI; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number F5CQF252RT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient age (b)(6) underwent an ep study with a webster compli catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis.The patient suffered a cardiac perforation and pericardial effusion.During the catheter placement, the physician experienced difficulty placing the right ventricular catheter (and it may have perforated the right atrium at this time).The patient was not symptomatic until pacing stopped and then her blood pressure dropped into the 30's.A transthoracic echo was performed and the effusion was diagnosed.A pericardiocentesis was performed and the patient stabilized.The catheter in question was an f-curve fixed quad catheter.Additional information was received on the event.The physician¿s opinion on the cause of this adverse event was procedure related.He was having trouble advancing the catheters under no fluoroscopy and thinks he may have applied force on the tissue.Pericardiocentesis was performed.Patient outcome of the adverse event was improved.It is unknown if the patient required extended hospitalization because of the adverse event.A transseptal puncture was not performed.Prior to noting the cardiac tamponade, ablation was not performed.No ablation was performed.The event occurred during placement of the quadrapolar catheters with no fluoroscopy.Decanav catheter was already placed in the body.

• Brand Name: WEBSTER COMPLI
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12637462
• MDR Text Key: 280186315
• Report Number: 2029046-2021-01750
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: F5CQF252RT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention