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

Model Number D138502

Device Problems Material Perforation (2205); Obstruction of Flow (2423)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 00001633 number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an issue with perforation on dilator inside the patient occurred.When the transseptal needle was inserted into the dilator of the vizigo¿ sheath, the physician felt resistance.The sheath was removed from the patient and the dilator was flushed and there were pieces of the dilator that had been scraped off from the needle.The issue occurred before the catheter was inserted into the sheath.There was no occlusion when irrigating the sheath.It is unknown whether the sheath was either narrowed, partially blocked or completely blocked.The catheter/needle was still able to be moved through the sheath.No external damage was observed on the dilator.The dilator was flushed really well, as well as the sheath and the needle.The sheath and needle were inserted again, and the case was continued without any further incident.No adverse patient consequences were reported.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 30-aug-2021.The device evaluation was completed on 22-sep-2021.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 an issue with perforation on dilator inside the patient occurred.When the transseptal needle was inserted into the dilator of the vizigo¿ sheath, the physician felt resistance.The sheath was removed from the patient and the dilator was flushed and there were pieces of the dilator that had been scraped off from the needle.The issue occurred before the catheter was inserted into the sheath.There was no occlusion when irrigating the sheath.It is unknown whether the sheath was either narrowed, partially blocked or completely blocked.The catheter/needle was still able to be moved through the sheath.No external damage was observed on the dilator.The dilator was flushed really well, as well as the sheath and the needle.The sheath and needle were inserted again, and the case was continued without any further incident.No adverse patient consequences were reported.A picture showing a strange material in a gauze was received for analysis.However, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.The customer complaint cannot be confirmed based on the picture provided.The product was returned to biosense webster for evaluation and a visual inspection, an irrigation test, as well as an insertion withdrawal test were conducted.Only the dilator of the vizigo sheath was received for analysis.It was found in normal conditions.The irrigation test was performed to the dilator.No irrigation issues were observed.Also, the dilator was inserted into a vizigo sheath sample and no resistance was observed during the test.The dilator passed through the sheath normally.No issues were observed with the dilator.Since the sheath was not returned, no more testing was performed.A device history record was performed for the finished device 00001633 number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the as the device performed without any issue.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 analysis.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
• MDR Report Key: 12223556
• MDR Text Key: 263400221
• Report Number: 2029046-2021-01181
• 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: 06/29/2021

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: 04/26/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND TRANSSEPTAL NEEDLE; UNKNOWN BRAND TRANSSEPTAL NEEDLE