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

Model Number D138501

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

Patient Problem Cardiac Tamponade (2226)

Event Date 09/01/2020

Event Type  Injury  

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 00001373 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.Manufacturer's reference number: (b)(4).

Event Description

During a clinical trial, sponsored by biosense webster, inc., it was reported that a (b)(6)male patient underwent an atrial fibrillation (afib) cardiac ablation procedure on (b)(6) 2020 with a carto vizigo¿ 8.5f bi-directional guiding sheath - small and suffered cardiac tamponade requiring pericardiocentesis.During the procedure a carto vizigo¿ 8.5f bi-directional guiding sheath - small was used.At some point of the procedure, cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.Extended hospitalization was required as a result of the adverse event.Issue was resolved.Patient was discharged on (b)(6) 2020.The principal investigator assessed this event as severe, serious, possible related to the qdot micro¿ catheter, not related to the nmarq¿ multi-channel rf generator sw v3.0.1, not related to the nmarq¿ multi-channel rf generator sw v3.0.6, not related to the tx eco ext interface cable, not related to the tx eco cable dongle, not related to the bwi non-investigational devices (pump, tubing, cables, non-study catheters, etc) and causal index procedure related.In the opinion of the investigator, the adverse event was anticipated.No biosense webster, inc.Product malfunctions were reported.Since this event is related to a pre-market clinical study, it cannot be reported under the qdot catheter.Due to the implied relationship to the procedure, this event is being coded and reported under the carto vizigo¿ 8.5f bi-directional guiding sheath - small which is the listed marketed device used during the case.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irivine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10645756
• MDR Text Key: 210385761
• Report Number: 2029046-2020-01446
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001373
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR