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

Model Number D138502

Device Problem Partial Blockage (1065)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an issue with irrigation inadequate occurred.It was reported that during procedure, the device (including port, luer hub) was not irrigating.The issue was discovered during preparation of the vizigo¿.There was no alert from the irrigation pump.The physician noticed the irrigation issue because it was flushed with a syringe.The physician did not feel resistance between the catheter and the sheath.The issue was solved by replacing with a new sheath.A second device was used to complete the operation.There was no adverse event reported on patient.The irrigation inadequate issue is mdr reportable.

Manufacturer Narrative

Initial reporter address line 2 (cont.): (b)(6).Initial reporter phone: (b)(6).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.Manufacturer's reference number: (b)(4).

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 10-feb-2023.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an issue with irrigation inadequate occurred.It was reported that during procedure, the device (including port, luer hub) was not irrigating.The issue was discovered during preparation of the vizigo¿.There was no alert from the irrigation pump.The physician noticed the irrigation issue because it was flushed with a syringe.The physician did not feel resistance between the catheter and the sheath.The issue was solved by replacing with a new sheath.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Visual inspection, irrigation test, and a fourier transformed infrared spectroscopy (ftir) study of the returned device were performed following bwi procedures.Visual analysis revealed no damage nor anomalies on the sheath and the dilator.An irrigation test was performed, a syringe was connected to the stopcock of the device, and irrigation was attempted; however, a blockage of the irrigation feature was detected.A guidewire was introduced inside the hub and a blockage in this area was detected.The hub was cut and a ftir study was performed on the material occluding the irrigation feature and revealed that this material is methacrylate.Due to this finding, a supplier manufacturing investigation was required.The supplier manufacturing investigation concluded as follows: it was confirmed that the failure mode involved a blockage of the stopcock tubing.Subsequently, an internal corrective action has been opened to investigate the occluded luer hub complaints.Therefore, it was concluded that this issue is manufacturing related.A device history record (dhr) evaluation was performed for the finished device number 50000150 and no internal action was found during the review.Based on the dhr, the d4.Expiration date and h4.Device manufacture date have been updated.The issue reported by the customer was confirmed.The instruction for use (ifu) states that ¿before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli¿ and ¿flush and maintain continuous saline¿.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through the quality system.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 ¿ 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: 15979131
• MDR Text Key: 308525884
• Report Number: 2029046-2022-03110
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2022
• 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: UNK BRAND SHEATH; UNK_SMART TOUCH BIDIRECTIONAL SF