MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Catalog Number UNK_PREFACE SHEATH

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

Patient Problem Cardiac Tamponade (2226)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Manufacturing record evaluation cannot be conducted because no lot number was provided by the reporter.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation (afib), in which a biosense webster inc.(bwi) preface® guiding sheath with multipurpose curve was used, and suffered cardiac tamponade requiring pericardiocentesis.During the procedure following transseptal puncture, pericardial effusion was noted; however, the procedure continued.While ablating in the pulmonary veins, the patient became hypotensive.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.Multiple attempts have been made to gain clarification regarding this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8587209
• MDR Text Key: 144297837
• Report Number: 2029046-2019-03075
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PREFACE SHEATH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention