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

Model Number D-1327-05-S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Cardiac Tamponade (2226)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

There is no information regarding shaft proximity interference value or catheter proximity.Thermocool smarttouch bidirectional navigation catheter was zeroed after the initial warm-up phase, post catheter connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.There were no errors reported on any bwi equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Also, as the ablation catheter was inserted into the patient prior to the event and the physician believes this is procedure related, this event is being conservatively reported under the ablation catheter used.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.The device history record (dhr) for the lot number 17660458m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant product: non-biosense webster, inc - merit medical 8.5 french prelude sheath (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an endocardial/epicardial ablation procedure for idiopathic ventricular tachycardia with a thermocool smarttouch bidirectional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.After endocardial ablation, the physician removed the catheter from the body.While preparing for epicardial ablation, upon inserting the sheath, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram (ice).Pericardiocentesis yielded an unspecified amount of fluid.Patient was reported to be in surgery at the time of complaint report.Site of injury was identified and the issue was corrected.Patient required extended hospitalization as a result of the adverse event to ensure complete resolution of the injury.Patient fully recovered with no residual effects.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Physician indicated that he believes he lacerated an artery during epicardial sheath insertion.It was noted that the ablation catheter was not the source of the tamponade, as the ablation catheter was no longer in the body at the time of injury.No transseptal puncture was performed.Sheath in use was a merit medical 8.5 french prelude.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, or last ablation cycle time at the site of injury, as ablation was not being performed at the suspected time of injury (during epicardial sheath placement).There is no information regarding irrigated catheter flow setting.Patient received anticoagulant during the procedure with activated clotting time of 379 seconds.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 8/2/2017.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

An attempt was made to submit follow-up #2 on september 20, 2017.However, due to an outage affecting the esg or the cdrh emdr processing system we were unable to meet the report submission due date.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent an endocardial/epicardial ablation procedure for idiopathic ventricular tachycardia with a thermocool smarttouch bidirectional navigation catheter.After endocardial ablation, the physician removed the catheter from the body.While preparing for epicardial ablation, upon inserting the sheath, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram (ice).Pericardiocentesis yielded an unspecified amount of fluid.Patient was reported to be in surgery at the time of complaint report.Site of injury was identified and the issue was corrected.Patient required extended hospitalization as a result of the adverse event to ensure complete resolution of the injury.Patient fully recovered with no residual effects.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was evaluated for screening test and catheter passed.The force feature was working properly.Finally, the force sensor values were found within specifications.Then the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Additionally, a deflection and an irrigation test were performed and the catheter passed the tests.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.The catheter passed all specifications.The root cause of the cardiac tamponade remains unknown.The instructions for use states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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: 6730922
• MDR Text Key: 80628631
• Report Number: 9673241-2017-00585
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)170418(17)180331(10)17660458M
• 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,Followup,Followup,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17660458M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70