MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-11-S

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

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: carto 3 system, model #fg-5400-00j, s/n: (b)(4).Coolflow tubing set, model #d-1233-01-s, lot #764026.Carto 3 reference patch, model #d-1283-02, lot #ll010116.(b)(4) are related to the same incident.

Event Description

It was reported that a female patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav eco catheter and suffered a cardiac tamponade requiring pericardiocentesis.Initially, mapping was being conducted with the pentaray catheter, but it was causing frequent premature ventricular contractions.Catheter was changed to a smarttouch and mapping continued.A voltage map was created to confirm the origin of the arrhythmia.There was low voltage from the cardiac apex to the free wall, therefore mapping was completed quickly.During mapping phase, the patient became hypotensive and tamponade was confirmed.Pericardiocentesis yielded an unknown amount of fluid.Remainder of procedure was aborted.Blood pressure was stabilized and the patient was transferred to the intensive care unit.No ablation had been performed.There is no information regarding extended hospitalization.Patient outcome was improved at the time of complaint report.Physician's opinion regarding the cause of the adverse event is that it was related to patient condition.Factors cited that might have contributed to the adverse event included a large area of low voltage in the ventricle that could be secondary to a cardiac muscle issue.No transseptal puncture was performed.There is no information regarding the sheath used.Generator was set on power control mode.No ablation was performed.There is no information regarding irrigated catheter flow setting.There is no information regarding anticoagulation during the procedure.There were no error messages observed on any biosense webster equipment during the procedure.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5769384
• MDR Text Key: 48777989
• Report Number: 9673241-2016-00422
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17402601L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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): Life Threatening; Required Intervention