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

Model Number D138501

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The product has not returned for analysis; however, a video 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.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 ¿ small and a hemostatic valve separation issue occurred.It was reported that before the procedure, the physician tried to flush the hemostatic valve with saline; however, saline could not enter the hemostatic valve.A new device was used to complete the surgery.No adverse patient consequence was reported.Additional information was received on 9-feb-2022.It was reported that the saline could not be injected through the hemostasis valve of the vizigo¿ sheath.The hemostasis valve did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.The sheath was being used on the patient and no air enter the patient¿s body.This event did not require percutaneous or surgical removal and there was no blood return.The hemostatic valve separation issue was assessed as a mdr reportable product malfunction.The obstructed sheath issue was assessed as not mdr reportable.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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 18-apr-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred.It was reported that before the procedure, the physician tried to flush the hemostatic valve with saline; however, saline could not enter the hemostatic valve.A new device was used to complete the surgery.No adverse patient consequence was reported.Additional information was received on 9-feb-2022.It was reported that the saline could not be injected through the hemostasis valve of the vizigo¿ sheath.The hemostasis valve did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.The sheath was being used on the patient and no air enter the patient¿s body.This event did not require percutaneous or surgical removal and there was no blood return.Device evaluation details: a video showing issues with the irrigation of the sheath was received for analysis.Even if it can be related to the hemostatic valve failure reported, the video does not provide enough information, and no conclusion can be made.The customer complaint cannot be confirmed based on the video received.The product was returned to biosense webster for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of the hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.A device history record review was performed for the finished device 00001821 number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.An internal corrective action has been opened to address this issue.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4) during an internal review on 12-may-2022, it was noted that the device manufacture date was inadvertently omitted on follow up report #2 (mwr-18042022-0001168284).Therefore, h4.Device manufacture date has been updated on this report.

• 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: 13546210
• MDR Text Key: 289887712
• Report Number: 2029046-2022-00314
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2021
• 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: UNKNOWN BRAND SHEATH