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

Model Number D138502

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

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 patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium and the patient suffered a thrombosis which required surgical intervention.In addition, clots were removed from the left ventricle.While performing the transseptal puncture they were able to see a clot forming on the distal end of the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The pentaray was going through the sheath at the time.The physician decided to pull everything into the right atrium.They did not know if the clot was dislodged in the left atrium or brought into the right atrium with the sheath and catheters.They had visibility with intracardiac echo using the soundstar catheter.They used intracardiac echo to clear any clots in the left ventricle and everything was pulled out.The procedure was aborted at that time.Only the soundstar, pentaray, and carto vizigo¿ 8.5f bi-directional guiding sheath - medium were used during the procedure and in the body at the time of the event.The ablation catheter was prepped but never introduced into the patient body and no ablation was performed.The physician gave heparin and act was over 400 during the procedure.At the time of the call, the patient is still in the ep lab and the health care professionals are trying to bring the patient out of anesthesia.After following up with the physician the issue of the possible clot formation is no longer an issue, and the patient after being in observation for 24hrs has been released.Additional information was received on the event.The system did not present any error messages and the physician/user did not see any product problem.There were not any issues related to temperature and flow on the catheter as the ablation catheter was never inserted into the body.No ablation was performed.The ablation catheter was never inserted into the body.No other products had issues.A clot formed on the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.There have been no neurological symptoms experienced by the patient since completion of the procedure.Since the thrombosis event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The clots removed from the patient was assessed as a mdr reportable malfunction.

Manufacturer Narrative

Additional information was received on 25-mar-2022.The patient is a 59 year old female.The physician believes patient may have a clotting disorder and does not believe it was bwi product.The physician pulled all catheters and the vizigo out of the left atrium, no other intervention was provided.The patient outcome of the adverse event is fully recovered with no residual effects.The patient did not require extended hospitalization because of the adverse event.Therefore, updated a 2.Patient age at the time of event, a 2.Age unit and a 3.Gender fields.In addition, the physician information was provided.Therefore, updated e.Initial reporter section.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation (b)(6) 2022.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: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 01-aug-2022.It was reported that a 59 year old female patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium and the patient suffered a thrombosis which required surgical intervention.In addition, clots were removed from the left ventricle.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of the c3 system, electrical, irrigation, and deflection test.Visual analysis of the returned sample revealed that no physical damage was observed.Clot residues were observed in the hub during the decontamination process and the dilator was not returned for analysis.Per the event, several tests were performed.The device was recognized in the carto 3 system and no electrical issues were observed.In addition, the product 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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿ issue.-investigation findings: environment problem identified (c15) / investigation conclusions: cause not established (d15) / component code: hub (g02021) were selected as related to the customer¿s reported ¿clot¿ issue.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: 13895960
• MDR Text Key: 288053352
• Report Number: 2029046-2022-00622
• 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,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female