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

Catalog Number D138502

Device Problems Partial Blockage (1065); Material Integrity Problem (2978)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

On 9-oct-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and it was not flushing well.It was reported that the area around the hemostatic valve was found to be kinked on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The caller stated the "tubing" coming off the sheath was visually bent and not flushing well.When the sheath was replaced, the issue resolved.Additional information received indicating the hemostatic valve was not dislodged inside or outside of the hub and the brim cap/hub did not detach from the sheath.The issue occurred while the device was being used on the patient but no air entered the patient¿s body.No significant blood loss observed and the issue occurred prior to transseptal.An ¿stsf¿ catheter was in the sheath but there was no resistance.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: on 29-oct-2023, it was noticed the incorrect manufacturer's ref # was reported in section h10 of the 3500a supplemental mdr (follow-up) # 1.The incorrect number reported is (b)(4).The correct # is (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and it was not flushing well.It was reported that the area around the hemostatic valve was found to be kinked on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The caller stated the "tubing" coming off the sheath was visually bent and not flushing well.When the sheath was replaced, the issue resolved.On 10-oct-2023, additional information was received indicated the physician requested a new sheath because he was not comfortable nor satisfied with how the irrigation port was functioning.No patient consequence was observed.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection was performed following bwi procedures.Visual analysis revealed that the three-way valve has one way completely broken.The damage observed could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.A device history record was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17909699
• MDR Text Key: 325358263
• Report Number: 2029046-2023-02275
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138502
• Device Lot Number: 00002378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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: UNK_SMART TOUCH BIDIRECTIONAL SF.