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

Model Number D138502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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 female patient ((b)(6)year old, (b)(6) lb) underwent atrial fibrillation (afib) ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath - medium and suffered cardiac tamponade requiring pericardiocentesis.It was reported during an atrial fibrillation case, a pericardial effusion was noticed.Event discovered during use of biosense webster products after transseptal while exchanging sheaths.The physician wasn't sure what happened, they exchanged the transseptal sheath (sl1, abbott) to a vizigo and noticed the sheath was through the top of the map that was made.The physician commented they didn't feel any resistance with moving the sheath.The patient had fully recovered (no residual effects) after 2 extra days in intensive care unit (icu).The pericardial effusion was confirmed by intracardiac echo (ice).Caller reported that the medical intervention provided was a pericardiocentesis and 800 cc of fluid was removed.No ablation was performed before effusion was noticed.Irrigated catheter wasn't used at this point in the procedure.Ablation catheter wasn't inserted.No error messages were observed on biosense webster equipment during the procedure.The event is conservatively being reported under the vizigo sheath.

Manufacturer Narrative

It was reported that a female patient (65 year old, 160lb) underwent atrial fibrillation (afib) ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath - medium and suffered cardiac tamponade requiring pericardiocentesis.It was reported during an atrial fibrillation case, a pericardial effusion was noticed.Event discovered during use of biosense webster products after transseptal while exchanging sheaths.The physician wasn't sure what happened, they exchanged the transseptal sheath (sl1, abbott) to a vizigo and noticed the sheath was through the top of the map that was made.The physician commented they didn¿t feel any resistance with moving the sheath.The patient had fully recovered (no residual effects) after 2 extra days in intensive care unit (icu).No ablation was performed before effusion was noticed.Irrigated catheter wasn't used at this point in the procedure.Ablation catheter wasn't inserted.No error messages were observed on biosense webster equipment during the procedure.The event is conservatively being reported under the vizigo sheath.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 00001328 identified no internal actions related to the reported complaint condition.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Based on the completed mre, the h4.Device manufacture date has been populated with 5/20/2020.H6.Component code of ¿g07002¿ (appropriate term/code not available) was used to represent no findings available (c20) because device not returned.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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10552418
• MDR Text Key: 207534199
• Report Number: 2029046-2020-01299
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001328
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT SL1 TRANSSEPTAL NEEDLE; THMCL SMTCH SF UNID, TC, F; ABBOTT SL1 TRANSSEPTAL NEEDLE; THMCL SMTCH SF UNID, TC, F
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73