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

Model Number D138501

Device Problems Backflow (1064); Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an unknown patient underwent a premature ventricular contraction (pvc) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿small.The hemostatic valve was damaged.Air removal was performed because the bubble entered the sheath.When ssmap was created, error7 was displayed.Removed all cables in front of piu and restarted.After starting up, there was no problem immediately after putting cables one by one.After a while, error 7 appeared again.Restarted piu and replaced cables for ablation catheter.The procedure was continued because no error occurred.After vizigo insertion, the tip was bent on fluoroscopy.There was no problem with catheter insertion, and the procedure was continued.When sound was inserted into vizigo and replaced with stsf, the hemostatic valve was damaged.Air removal was performed because the bubble entered the sheath.The procedure was ended normally.Air was not being introduced into the patient.The physician did not performed any maneuver to eliminate bubbles.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.No blood return was observed.Bent tip/spline is not mdr-reportable.Air flow into the side port is mdr-reportable.Hemostatic valve separation is mdr-reportable.

Manufacturer Narrative

On 13-aug-2021, bwi received additional information regarding the event.Air was not being introduced into the patient.The physician did not performed any maneuver to eliminate bubbles.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.No blood return was observed.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

On 28-oct-2021, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 00001591 number, and no internal actions related to the reported complaint condition were identified.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

On 10-jan-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an unknown patient underwent a premature ventricular contraction (pvc) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿small.The hemostatic valve was damaged.Air removal was performed because the bubble entered the sheath.When ssmap was created, error7 was displayed.Removed all cables in front of piu and restarted.After starting up, there was no problem immediately after putting cables one by one.After a while, error 7 appeared again.Restarted piu and replaced cables for ablation catheter.The procedure was continued because no error occurred.After vizigo insertion, the tip was bent on fluoroscopy.There was no problem with catheter insertion, and the procedure was continued.When sound was inserted into vizigo and replaced with stsf, the hemostatic valve was damaged.Air removal was performed because the bubble entered the sheath.The procedure was ended normally.Device evaluation details: the visual analysis revealed hemostatic valve in good conditions, also, the soft tip was bumped.Then, the distal sheath end was closed off with an adapter, the proximal end was connected to the pressure gage and a syringe was connected to the gage.After that, negative pressure was applied there were no air leaks or bubbles.Then, the test was repeated with positive pressure and no air leak or bubbles were detected.A device history record evaluation was performed for the finished device 00001591 number, and no internal actions related to the reported complaint condition were identified.The event described could not be confirmed as the device performed without any issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12292334
• MDR Text Key: 265566977
• Report Number: 2029046-2021-01302
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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: CARTO 3 SYSTEM (B)(6); UNSPECIFIED ABLATION CATHETER; UNSPECIFIED CATHETER CABLE; CARTO 3 SYSTEM (B)(6); UNSPECIFIED ABLATION CATHETER; UNSPECIFIED CATHETER CABLE