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

Model Number D-1282-08-S

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system model # m-4800-01, s/n: (b)(4).Smartablate generator, model # m-4900-07, s/n: (b)(4).Smart touch bidirectional catheter, model # d-1327-05-s, lot number unknown.Soundstar 3d catheter, model # m-5723-05, lot number unknown.St.Jude sl2 sheath, model and lot numbers unknown.(b)(4).Biosense webster manufacturer's ref.No.'s pi1-15p6hwc / pi1-15rb3kx are related to the same incident.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco catheter and suffered an air embolism with associated st segment elevation and hypotension.During the procedure, air was observed in the tubing connected to the pentaray catheter.Staff members were unaware of the point of entry.No intervention was administered.The sheath in use at the time of the event was a st.Jude medical sl2.Multiple attempts have been made to obtain clarification to this complaint, but no further information has been made available.

Manufacturer Narrative

On 12/14/2016, biosense webster received additional information regarding this complaint: the staff arrived at the conclusion that the fluid spike must have been left open, letting air in and keeping the fluid from flowing.This happened twice before the case, but never before or since.(b)(4).

• 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: 6176051
• MDR Text Key: 62537249
• Report Number: 9673241-2016-00867
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: UNKNOWN_D-1282-08-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: No
• 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