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

Catalog Number D138501

Device Problems Coagulation in Device or Device Ingredient (1096); Entrapment of Device (1212)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.During placement of the vizigo sheath in the superior vena cava (svc), the wire was inserted into the internal jugular vein due to insufficient holding of the wire and insufficient fluoroscopic confirmation.The spring coil portion of the wire strayed into a branch vessel of the internal jugular vein, got stuck, and could not be removed.After the wire was removed using a snare catheter (catheter for removal of intravascular foreign body), the tip of the vizigo guide wire was bent and had a thrombus adhered to it.There was no obstruction found on the sheath.Since the sheath itself showed no abnormality and no thrombus was observed during flushing, the sheath was continued to be used at the physician's discretion, and the pulmonary vein isolation (pvi) was completed without any problems.There was no patient consequence.The physician¿s opinion on the relationship between the event and the product was that the issue was related to the fluoroscopy and holding, and there was no problem with the biosense webster inc.(bwi) product.

Manufacturer Narrative

E 1.Initial reporter phone (cont.): (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.During placement of the vizigo sheath in the superior vena cava (svc), the wire was inserted into the internal jugular vein due to insufficient holding of the wire and insufficient fluoroscopic confirmation.The spring coil portion of the wire strayed into a branch vessel of the internal jugular vein, got stuck, and could not be removed.After the wire was removed using a snare catheter (catheter for removal of intravascular foreign body), the tip of the vizigo guide wire was bent and had a thrombus adhered to it.There was no obstruction found on the sheath.Since the sheath itself showed no abnormality and no thrombus was observed during flushing, the sheath was continued to be used at the physician's discretion, and the pulmonary vein isolation (pvi) was completed without any problems.There was no patient consequence.The physician¿s opinion on the relationship between the event and the product was that the issue was related to the fluoroscopy and holding, and there was no problem with the biosense webster inc.(bwi) product.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed that the guide wire was deformed close to the tip, and severely stretched at the tip area.In addition, during a microscopic inspection, thrombus residues were observed.Device history record was performed for the finished device 00002413 number, and no internal action related to the complaint was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.Both issues reported by the customer were confirmed.The damage observed with the guidewire could be related to the excessive force or manipulation of the device during the procedure.However, this cannot be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s 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).

Manufacturer Narrative

On 25-jan-2024, additional information was received.It was reported that the sheath itself had been discarded.Only the guidewire with the snare used for extraction was sent on (b)(6) 2024, 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).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18176189
• MDR Text Key: 328583060
• Report Number: 2029046-2023-02711
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138501
• Device Lot Number: 00002413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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 VASCULAR SNARE CATHETER
• Patient Sex: Female