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

Catalog Number D138502

Device Problem Material Perforation (2205)

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  picture was provided by the customer.Evaluation is still in progress.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.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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a sheath perforation issue occurred.It was also reported that when removing the carto vizigo¿ 8.5f bi-directional guiding sheath - medium using the guidewire, the tip went thru one of the irrigation holes on the sheath.This was noticed after the sheath was removed from the body.No patient consequence.Additional information was received.The physician did not comment on any difficulty removing the sheath.The carto vizigo¿ 8.5f bi-directional guiding sheath - medium provided guide wire appeared to have entered one of the distal irrigation holes on the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The dilator was not used during removal of the device.A picture was provided.The carto vizigo¿ 8.5f bi-directional guiding sheath - medium guide wire was associated with this complaint.After an initial review of the picture received and the issue reported of the guidewire tip went thru the irrigation hole on the sheath, the event was assessed as mdr reportable for a sheath perforation.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.When removing the carto vizigo¿ 8.5f bi-directional guiding sheath - medium using the guidewire, the tip went thru one of the irrigation holes on the sheath.This was noticed after the sheath was removed from the body.No patient consequence.The picture investigation was completed on 14-sep-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip of the vizigo sheath was observed damaged at the irrigation hole, the guidewire was passed through the irrigation hole.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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: 17557391
• MDR Text Key: 321260378
• Report Number: 2029046-2023-01788
• 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
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Catalogue Number: D138502
• Device Lot Number: 00002332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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
• Treatment: THMCL SMTCH SF BID, TC, D-F; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER