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

Model Number D138502

Device Problem Partial Blockage (1065)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an occlusion issue occurred.It was reported that the flush valve on the vizigo sheath would become occluded when the sheath was manipulated.The physician completed the procedure without replacing it.The case continued without further incident or harm.The carto 3 system is operating per specs and is not responsible for the product issue.Additional information received indicates there was no resistance when they were trying to put the catheter into the sheath or when they were trying to withdraw it from the sheath.The irrigation occlusion was partial, depending how the tubing was positioned in relation to the valve, the tubing would bend and occlude.When the tubing was straightened, the occlusion cleared, and flow could resume normally.The occlusion was in the tubing at the base of the valve.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was functional and provided no resistance to the catheter.The catheter/needle was still able to be moved through the sheath.Catheter was in the sheath already when the tubing became occluded.

Manufacturer Narrative

On (b)(6)-2021, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed that field g1.Manufacturer site city, was misspelled in the 3500a initial medwatch report as ¿irivine¿ and has now been corrected to ¿irvine¿.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an occlusion issue occurred.It was reported that the flush valve on the vizigo sheath would become occluded when the sheath was manipulated.The physician completed the procedure without replacing it.The case continued without further incident or harm.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi then conducted visual inspection and a functional test of the side port.Visual analysis of the returned sample revealed a bent shaft on the vizigo sheath.Then, the returned sample was connected to a cool flow pump and no leakage was observed.The irrigation of the device working correctly.A device history record was performed, and no internal action related to the reported complaint were identified.As part of quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the instructions for use (ifu): before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.The bent shaft could be related to the handling of the device during shipment.The customer reported event could not be confirmed as the device was returned without irrigation issues.Although no product defect was identified.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additionally, a picture showing the sheath handle was provided by the customer to aid in the analysis.However, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.Customer complaint cannot be confirmed.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
• MDR Report Key: 12138433
• MDR Text Key: 261777325
• Report Number: 2029046-2021-01073
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM