MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-04-S

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

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.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 medical products: carto 3 system (model# m-4800-01 serial# (b)(4)); stockert generator (model# unknown serial# unknown); coolflow pump (model# unknown serial# unknown); pentaray nav eco catheter (model# d-1282-07-s lot# 17507949l); soundstar eco catheter (model# m-5723-17 lot# unknown); webster cs with auto id catheter (model# d-1353-04-s lot# 17551754m).(b)(4).

Event Description

It was reported that a female patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® bi-directional navigation catheter and suffered a cardiac tamponade, which required pericardiocentesis.During the ablation phase, after ablation for approximately 10 minutes, the patient developed a pericardial effusion.The patient¿s pressure had dropped and the patient was given fluids to stabilize.A pericardiocentesis was performed and 400cc of blood was removed.The patient left the procedure room in stable condition and was observed overnight in the intensive care unit.The patient did require extended hospitalization due to management of the pericardial drain.The patient¿s condition has since improved.The physician¿s opinion on the cause of the adverse event is a complicated transseptal puncture.It is noted that it took the physician multiple attempts to get transseptal access.In addition, the physician also reported using a transseptal sheath he had not used before.The patient received heparin as an anticoagulant; however the activated clotting time is unknown.A transseptal puncture was performed with an unknown needle.The generator was in power control mode.The irrigation flow was set to 8cc/min and 15cc/min.There were no errors reported by the biosense webster systems during the procedure.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 6119478
• MDR Text Key: 60624869
• Report Number: 9673241-2016-00801
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: (01)10846835009194(11)160817(17)170731(10)17546841M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1327-04-S
• Device Catalogue Number: D132704
• Device Lot Number: 17546841M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2016
• 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): Hospitalization; Life Threatening; Required Intervention