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); Device-Device Incompatibility (2919)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

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.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 a paroxysmal atrial fibrillation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a tip damaged issue occurred.One or more of the octaray catheter splines entered and damaged one of the side ports of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, damaging the sheath.It was noticed when the physician mentioned resistance while inserting the octaray catheter into the sheath and felt a little "pop." this is believed to be when the octaray catheter came out of the sheath tip, damaging the side port.The physician also mentioned something might be unusual on x-ray (when the side hole became damaged).At the end of the procedure, the sheath and catheter were removed intact, and the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium side hole damage was observed.There was no patient consequence.Additional information was received.The section that the issue was observed was on the distal tip of the sheath with the side holes.Looked like it was torn on the x-ray and after removed.The hemostatic valve did not dislodge inside the hub and did not dislodge outside of the hub.The brim cap / hub did not become detached from the sheath.No air entered the patient¿s body.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.One or more of the octaray catheter splines entered and damaged one of the side ports of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, damaging the sheath.It was noticed when the physician mentioned resistance while inserting the octaray catheter into the sheath and felt a little "pop." this is believed to be when the octaray catheter came out of the sheath tip, damaging the side port.The physician also mentioned something might be unusual on x-ray (when the side hole became damaged).At the end of the procedure, the sheath and catheter were removed intact, and the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium side hole damage was observed.There was no patient consequence.The device evaluation was completed on 05-mar-2024.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 tip of the sheath was found broken and also, the connector was found cut off.A dilator and a good catheter sample were used; however, no resistance was detected.No other damages or anomalies were observed.A device history record was performed for the finished device batch number, and no internal actions were identified.Since the device tip was found broken, this issue could be related to both issues reported by the customer; therefore, the customer complaint was confirmed.The root cause of the damage observed could be related to the excessive force or manipulation of the device during the procedure; however, this can not 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) during an internal review on 21-feb-2024, noted a correction to the 3500a follow-up #1 as the following additional information was inadvertently omitted: there was no reported damage to the octaray catheter noted.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation 20-feb-2024.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 ¿ 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: 18704552
• MDR Text Key: 336413088
• Report Number: 2029046-2024-00496
• Device Sequence Number: 1
• Product Code: DYB
• 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,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138502
• Device Lot Number: 00002507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• 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: CARTO 3 SYSTEM.; UNK_OCTARAY NAV.