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

Model Number D138502

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and the guide wire broke.It was reported that during a procedure when "trying to withdraw the wire from the body, it was met with resistance and they noticed that it was sheared and damaged within the body." they reported that the damage on the guide wire was confirmed on the fluoroscopy imaging.To troubleshoot the physician advanced the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and removed the entire assembly without patient consequence.They replaced the sheath, the issue was resolved, and the procedure was continued.Additional information received indicated no damage was observed on the sheath.The guidewire could not be withdrawn into the sheath.It appeared to get stuck on something within the body (beyond the sheath) and could not be pulled back.Once the sheath was advanced over the wire the entire assembly was removed.It was not attempted to move the guidewire within the sheath while it was in the body once resistance and shearing of the wire was noticed.The resistance resulted in high force to move guidewire.Guidewire was not stuck within sheath it was stuck to something within the body.There was a visible damage on the guidewire, there was a breakage.Needle was not used.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and the guide wire broke.It was reported that during a procedure when "trying to withdraw the wire from the body, it was met with resistance and they noticed that it was sheared and damaged within the body." they reported that the damage on the guide wire was confirmed on the fluoroscopy imaging.To troubleshoot the physician advanced the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and removed the entire assembly without patient consequence.They replaced the sheath, the issue was resolved, and the procedure was continued.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the device had no physical damage.The guide wire was broken in two.The incorrect insertion of the guide into the sheath cloud be the cause of the damage; physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.The lot number was verified during the product evaluation as 60000050 and has been populated into field d4.Lot.Based on the lot number verification, the manufactured date and expiration date have also been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.A device history record was performed for the finished device with batch number 60000050, and no internal actions were identified.The guidewire broken issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 16461850
• MDR Text Key: 310452262
• Report Number: 2029046-2023-00421
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 60000050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC.