MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/14/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient, weight ((b)(6), underwent a paroxysmal atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath medium.The patient suffered cardiac tamponade requiring pericardiocentesis.The patient suffered a pericardial effusion during transseptal access procedure, prior to accessing the left atrium.Mapping of the right atrium with the pentaray catheter was completed.And after what was believed to be a successful first transseptal puncture, just prior to the second transseptal puncture, it was noticed that the patient's blood pressure had dropped.Intracardiac echo revealed the effusion.The procedure was stopped, epi was administered and a pericardiocentesis was in progress at the time of the call.The patient was stabilizing.It was undetermined if biosense webster, inc.Products contributed to the patient event.No ablation had been performed, mapping of right atrium only.It was believed that possibly the first transseptal puncture resulted in the effusion.Patient history: severe cardiac heart disease, kidney failure, fluid build up.Additional information: this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Physician believes he may have poked through the right atrial appendage when attempting to go up the superior vena cava (svc) looking to make transseptal.The ep procedure was immediately terminated.A pericardiocentesis was performed to remove fluid from the pericardium caused by the pericardial effusion.Patient outcome of the adverse event wat that the patient was stabilized.The physician asked to keep the patient overnight to oversee the patient¿s recovery.Transseptal was performed.Sjm brk needle was used for the transseptal puncture.No ablation performed; therefore, no evidence of a steam pop.The event occurred during the transseptal phase.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2021.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-001000113.

Manufacturer Narrative

It was reported that a 57-year-old male patient (300+lbs) underwent a paroxysmal atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The patient suffered cardiac tamponade requiring pericardiocentesis.The device evaluation was completed on 09-dec-2021.Visual analysis revealed no damage or anomalies on the device.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Per the event, several tests were performed.The carto 3 and electrical features were tested and no issues were observed.In addition, the device was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A device history record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12760912
• MDR Text Key: 284302280
• Report Number: 2029046-2021-01897
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• 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
• Treatment: GENERIC - PENTARAY.; NON BWI-ST. JUDE MEDICAL BRK NEEDLE.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 136 KG