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

Model Number D138502

Device Problem Material Perforation (2205)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 03/23/2021.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).

Event Description

It was reported that a patient had an atrial fibrillation (afib) ablation procedure with a carto vizigo" 8.5f bi-directional guiding sheath  medium and there was a perforation on dilator issue occurred.When advancing the needle through the carto vizigo" 8.5f bi-directional guiding sheath  medium, the physician noted that the needle felt like it was scraping the dilator inside the sheath.It was reported that the vizigo sheath is used frequently at this account and it was the first time the physician felt this happen.The sheath was not yet in the body at the time.It was replaced with a competitors sheath instead of another vizigo sheath since they did not have any more medium curve available.The procedure was continued.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as a mdr reportable perforation on the dilator malfunction issue.

Manufacturer Narrative

The device evaluation was completed on 4/5/2021.It was reported that a patient had an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and there was a perforation on dilator issue occurred.When advancing the needle through the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, the physician noted that the needle felt like it was scraping the dilator inside the sheath.It was reported that the vizigo sheath is used frequently at this account and it was the first time the physician felt this happen.The sheath was not yet in the body at the time.It was replaced with a competitor¿s sheath instead of another vizigo sheath since they did not have any more medium curve available.The procedure was continued.No patient consequence was reported.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test.Visual analysis of the returned device revealed that no damage or anomalies were observed on the carto vizigo sheath.Additionally, the device was x-rayed to verify the integrity in the internal diameter of the dilator and it was found in good conditions, no obstructions or damage was observed.Functional test was performed in accordance with bwi procedures.The device was working correctly, and no obstructions or frictions was observed during the analysis.A device history record was performed and no internal actions related to the reported complaint were identified.As part of quality process all devices are manufactured, inspected, and released to approved specifications.Although no perforation or friction issues could be reached on the cause of the reported event; the instructions for use contain the following precautions; do not attempt to use a guidewire larger than 0.032 inches in diameter with the dilator provided.Doing so may compromise the structural integrity of the dilator or the guidewire and/or lead to the failure of the sheath or guidewire being used.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11559223
• MDR Text Key: 266253330
• Report Number: 2029046-2021-00402
• 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
• Report Date: 02/23/2021

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: 12/30/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI -AGILIS SHEATH