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

Model Number D138501

Device Problems Partial Blockage (1065); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

The product has not returned for analysis.However; a picture was provided by the customer.Evaluation is still in progress.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) procedure with carto vizigo¿ 8.5f bi-directional guiding sheath - small.A huge clot of coagulum came out of sheath and the irrigation was inadequate.Carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was used for transseptal access in an atrial fibrillation (afib) procedure.Female patient had persistent foramen ovale so access was done only using sheath with dilator and wire without problems.After advancing into left atrium, physician tried to aspirate blood to make sure left access was correct.Physician could not retract blood or anything else.Epicardial access could be ruled out.Also applying contrast via sheath was not possible so they suggested to use new sheath.After retracting sheath, i asked the nurse to flush sheath when outside.This was only possible using force and a big syringe.A huge clot of coagulum came out of sheath (>4cm long).The new sheath was used without problems to treat patient.No other events.Physician said the thrombus might have been scraped off the septum when transseptal access.Any other thrombus before procedure was ruled out in transesopaguel echo.The surgery was delayed 15 minutes due to the reported event.There were no patient consequences.Additional information was received.No biosense webster, inc.Catheter was used before the incident.They changed to a new sheath and performed procedure as normally.Today again they asked physician if there was any late consequence for the patient and he said patient was fine and already returned home.For the patient it was a completely normal procedure as planned.The system did not present any error messages nor did the physician/user see any product problem.There were no issues related to temperature and flow on the catheter.Coagulum was found in sheath before ablation; therefore, generator parameters and catheters settings were not provided.Patient took anticoagulation drugs and heparin was administered after transseptal via peripheral iv line.The patient has not exhibited any neurological symptoms since the procedure was completed.Physician said coagulum is definitely excessive but might have been scraped off endocardium / or collected during transseptal puncture.The risk assessed by the physician is that if the coagulum would have moved when trying to flush contrast agent into the left atrium, the patient would have been severely under risk for coronary block (heart attack) or stroke.The patient outcome of the adverse event is fully recovered with no residual effects.The thrombus was assessed as a mdr reportable thrombosis adverse event.Since the 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 inadequate irrigation of the sheath was also assessed as mdr reportable.

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) during an internal review on 02-oct-2022, noted a correction to the 3500a initial as missing the physician information.Therefore, updated section, "e.Initial reporter".

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 19-oct-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

It was reported that a female patient underwent an atrial fibrillation (afib) procedure with carto vizigo¿ 8.5f bi-directional guiding sheath - small.A huge clot of coagulum came out of sheath and the irrigation was inadequate.Carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was used for transseptal access in an atrial fibrillation (afib) procedure.Female patient had persistent foramen ovale so access was done only using sheath with dilator and wire without problems.After advancing into left atrium, physician tried to aspirate blood to make sure left access was correct.Physician could not retract blood or anything else.Epicardial access could be ruled out.Also applying contrast via sheath was not possible so they suggested to use new sheath.After retracting sheath, i asked the nurse to flush sheath when outside.This was only possible using force and a big syringe.A huge clot of coagulum came out of sheath (>4cm long).The new sheath was used without problems to treat patient.No other events.Physician said the thrombus might have been scraped off the septum when transseptal access.Any other thrombus before procedure was ruled out in transesopaguel echo.The surgery was delayed 15 minutes due to the reported event.There were no patient consequences.The investigation was completed on 18-nov-2022.A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, a clot was observed.Also, the device was not observed on the photo provided.The clot observed was related to the customer event reported.Due to this condition, the customer complaint was confirmed.The issue reported by the customer was confirmed based on the picture received.This product issue will be addressed through bwi's quality system.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.According to the picture provided by the customer, a clot was observed.However, the device was returned and visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The device features were tested and no issues were observed.A device history record was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.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 the quality process, all devices are manufactured, inspected, and released to approved specifications.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¿ and ¿irrigation inadequate - sheath¿ issue on the device analysis.Investigation findings: appropriate term/code not available (c22) and environment problem identified (c15)/ investigation conclusions: cause not established (d15) were selected as related to the ¿photo analysis¿, ¿adverse event¿ and ¿irrigation inadequate ¿ sheath¿ issues reported 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).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15526341
• MDR Text Key: 301011198
• Report Number: 2029046-2022-02369
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00002026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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: UNKNOWN BRAND SHEATH.
• Patient Outcome(s): Life Threatening
• Patient Sex: Female