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

Model Number D138503

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with two (2) carto vizigo¿ 8.5f bi-directional guiding sheath -large.There was resistance and the sheath was blocked by silicon.Dilatator does not fit in the sheath.There is a massive resistance in the sheath.No consequences for patient.New sheath was required.There was no physical damage on sheath/dilator.Sheath was blocked by silicon.It was not completely visible if the sheath either narrowed, partially blocked or completely blocked.The dilator was still able to be moved through the sheath with much increased effort.The dilator was not stuck in the sheath.There was no patient consequences.Sheath was blocked by silicon at the valve with transparent wall.A white silicon-like substance could be seen in the sheath.It was identified because it was visible.The silicon was found on both devices.Resistance with sheath is not mdr-reportable.Foreign material on usable length of catheter is mdr-reportable.This report is for the 1st of 2 vizigo sheaths.The other sheath was reported in manufacturer report number 2029046-2022-01722.

Manufacturer Narrative

On 24-aug-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: visual analysis revealed no damage or anomalies on the sheath and the vessel dilator returned.No foreign material was found.The dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt.No obstructions were detected.The dilator's outer diameter was measured, and dimensions were found within specifications.Due to the resistance issue, an internal action was opened.A device history record review was performed for the finished device 00001972 number, and no internal actions related to the complaint were found during the review.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 -LARGE
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15118799
• MDR Text Key: 304135165
• Report Number: 2029046-2022-01721
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2022
• 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