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

Catalog Number D138502

Device Problems Break (1069); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure using carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The guidewire broke inside the patient and the patient required surgical intervention to remove it.The guiding wire of the vizigo¿ sheath broke inside the vein of the patient.The patient was punctured in the groin area and the wire was pushed forward inside the vein (this is normal procedure).However, approximately 5 cm proximal from the puncture site the wire got stuck and formed a knot.When pulling it back, the wire tore and the knotted piece remained inside the patient¿s vein.It could not be retracted, and the patient had to undergo surgery to remove it.Fragments were generated.There was no damage to the electrodes because the vizigo¿ sheath itself was not involved in the event.The guide wire that was used to guide the vizigo¿ sheath into the heart is the defective product that tore.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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

On 19-dec-2023, the product investigation was completed as the complaint device was not returned.It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure using carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The guidewire broke inside the patient and the patient required surgical intervention to remove it.The guiding wire of the vizigo¿ sheath broke inside the vein of the patient.The patient was punctured in the groin area and the wire was pushed forward inside the vein (this is normal procedure).However, approximately 5 cm proximal from the puncture site the wire got stuck and formed a knot.When pulling it back, the wire tore and the knotted piece remained inside the patient¿s vein.It could not be retracted, and the patient had to undergo surgery to remove it.Fragments were generated.There was no damage to the electrodes because the vizigo¿ sheath itself was not involved in the event.The guide wire that was used to guide the vizigo¿ sheath into the heart is the defective product that tore.Photo analysis: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the guidewire was observed knotted.The damage observed could be related to the manipulation of the wire during introduction into the dilator, however, this cannot be conclusively determined.A device history review (dhr) was performed for the finished device 60000233 number, and no internal actions related to the complaint were found during the review.Based on the completed dhr, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The issue reported by the customer was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate to find the root cause of the complaint.The instructions for use contain the following recommendation: during insertion over the guidewire, use caution not to create excessive bends in this device.This may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly.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.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: (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: 18270462
• MDR Text Key: 329775766
• Report Number: 2029046-2023-02825
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138502
• Device Lot Number: 60000233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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
• Patient Outcome(s): Required Intervention