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

Model Number D138501

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 7/12/2021.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: (b)(4).

Event Description

It was reported that a male patient underwent a pulmonary vein isolation ablation procedure with a carto vizigo" 8.5f bi-directional guiding sheath - small and suffered a cardiac tamponade which required a pericardiocentesis.Initially, it was reported that the physician performed a transeptal puncture and he tried to aspirate from the carto vizigo" 8.5f bi-directional guiding sheath - small, but it was not possible.He tried again, but it did not work.He removed the carto vizigo" 8.5f bi-directional guiding sheath - small from the patient and continued the procedure with an agilis sheath and performed another transeptal puncture.The carto vizigo" 8.5f bi-directional guiding sheath  small was examined and there was no damage in the valve seen.Moreover, the physician said he did not feel anything different when inserting the dilator.It does not look like the dilator was inserted in an angle with force, since the valve did not look damaged.The patient had some epicardial effusion before the procedure.After the procedure, the epicardial effusion was a bit more pronounced.After a discussion with the physician, he stated that he does not think that the issue with the carto vizigo" 8.5f bi-directional guiding sheath - small was the cause of the increase in the epicardial effusion.He thinks that it was probably due to procedure (the second transeptal) and the anatomy of the patient.This epicardial effusion event was assessed as patient event non serious and therefore, not mdr reportable.Additional information was received on 16-june-2021.Five hours post procedure, the patient had a cardiac tamponade.The patient fully recovered.It was unknown if the patient received treatment or extended hospitalization for the event.Graph, dashboard, vector and visitag force visualization features were used during the procedure.Stability was 25%, 3 grams, 3 seconds.Ablation index color option was used.The physicians opinion was that it was due to procedure.However, it has been classified by the hospital as product malfunction.Additional information was received on 13-jul-2021.Five hours post procedure the patient had a cardiac tamponade.The patient fully recovered.The issue in this event was related to the carto vizigo" 8.5f bi-directional guiding sheath  small.The patient had some epicardial effusion before the procedure.After the procedure, the epicardial effusion was a bit more pronounced.The doctors did not raise concerns about it.Moreover, after a discussion with the physician, he stated that he did not think that the issue with the carto vizigo" 8.5f bi-directional guiding sheath  small was the cause of the increase in the epicardial effusion.He thought that it was probably related to the second transeptal and the anatomy of the patient.The last information provided by the physician is that the patient recovered properly after the pericardiocentesis.The additional information received on 16-june-2021 stated that the adverse event was a cardiac tamponade.Since this cardiac tamponade event is life threatening and required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.The awareness date for this event is (b)(6) 2021.In addition, it was assessed to report this event under the carto vizigo" 8.5f bi-directional guiding sheath - small as we cannot rule out that the carto vizigo" 8.5f bi-directional guiding sheath - small when attempting to draw back, the physician could not and this could be because they entered the pericardial space.The obstructed sheath issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

Manufacturer Narrative

It was reported that a male patient underwent a pulmonary vein isolation ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small and suffered a cardiac tamponade which required a pericardiocentesis.In addition, it was reported that the physician performed a transeptal puncture and he tried to aspirate from the carto vizigo¿ 8.5f bi-directional guiding sheath - small, but it was not possible.He tried again, but it did not work.He removed the carto vizigo¿ 8.5f bi-directional guiding sheath - small from the patient and continued the procedure with an agilis sheath and performed another transeptal puncture.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was examined and there was no damage in the valve seen.Moreover, the physician said he did not feel anything different when inserting the dilator.It does not look like the dilator was inserted in an angle with force, since the valve did not look damaged.The investigation was completed on 28-jul-2021.An analysis was performed on the picture that was provided by the customer.A picture showing sheath hub was received for analysis, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.A manufacturing record evaluation was performed for the finished, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The product analysis was performed as appropriate in order to find root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, deflection, pump, ecg and carto tests of the returned device.Visual analysis of the returned sample revealed multiple kinks in the shaft of the vizigo sheath.The root cause of the kinks in the shaft could be related to the shipping process but this cannot be conclusively determined.The hemostatic valve was inspected and it was found in good normal condition.Per the event, several tests were performed.The device was deflecting and flushing correctly since no obstruction was noticed during the testing.Carto test was performed, in accordance with bwi procedures.The returned sample was connected to carto 3 system and black rings were displayed in the screen.Therefore, electrical test was performed, and the sheath failed, no electrical readings were observed on electrodes #03 and #04.A failure analysis was performed, and the sheath was dissected, the electrical wires were found broken causing the improper electrical signal.The electrical/visualization failure could not be related to the adverse event reported.A device history records (dhr) was performed for the finished device batch number, and no internal actions were identified.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: the visualization issue.Disconnect and reconnect the catheter and ensure good connection.If that does not resolve the problem, replace cable or the catheter.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) and appropriate term/code not available (c22) / investigation conclusions: no problem detected (d14) and cause not established (d15) were selected as related to the customer¿s reported ¿adverse event¿ and ¿obstructed sheath¿ issue.Investigation findings: mechanical problem identified (c07) and open circuit (c0205) / investigation conclusions: cause not established (d15)/ component code: rod/shaft (g04112) and electrical lead/wire (g02015) were selected as related to the biosense webster inc.Product analysis lab findings of the ¿bent shaft (kinks)¿ and ¿wires broken¿.H6. investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.  if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000925621.

• 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
• MDR Report Key: 12167913
• MDR Text Key: 266303430
• Report Number: 2029046-2021-01119
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI- AGILIS SHEATH; THERMOCOOL® SMARTTOUCH® SF CATHETER; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention