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

Model Number D-1348-01-S

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

There is no information regarding generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, irrigated catheter flow setting, or anticoagulation during the procedure.There were no errors or issues reported with any bwi products used during the procedure.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.(b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation and a cavotricuspid isthmus (cti) ablation procedure for atrial flutter with a thermocool® smarttouch® sf bi-directional nav catheter and suffered a cardiac tamponade requiring pericardiocentesis.During ablation phase, after left pvi, a second physician continued the procedure.Right pvi (posterior, roof, anterior, bottom) was initiated but was not successfully completed.Conduction gap assessment was performed at the right pulmonary vein roof with a smarttouch sf catheter and a ¿ring¿ catheter (unspecified).Contact force of 80 grams or greater was reflected with the smarttouch sf catheter, which was attributed to cardiac movement secondary to inspiration.Immediately after, the patient became severely hypotensive, with the systolic blood pressure (sbp) decreasing from 140 mmhg to 70 mmhg.Tamponade was confirmed via body surface echocardiogram.Pericardiocentesis was performed until fluid was no longer visible (unspecified amount).Ten minutes later, the blood pressure recovered with a sbp of 110 mmhg.Additional left pvi was performed.Catheters were removed from the left atrium.Cti ablation was performed.Procedure was concluded.There is no information regarding extended hospitalization as a result of the adverse event.Patient condition has improved.There were no factors cited that may have contributed to the adverse event.It was noted that the adverse event may have occurred during mapping phase.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.Transseptal puncture was performed with an unspecified needle.There is no sheath information.Generator was set on power control mode.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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: 6646819
• MDR Text Key: 77743402
• Report Number: 9673241-2017-00484
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(11)170120(17)171231(10)17623290L
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: D-1348-01-S
• Device Catalogue Number: D134801
• Device Lot Number: 17623290L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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