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

Model Number D-1348-05-S

Device Problems Signal Artifact/Noise (1036); Use of Device Problem (1670)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/19/2017

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: st.Jude medical brk transseptal needle.St.Jude medical sl1 sheath.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a pulmonary vein isolation (pvi) ablation procedure for persistent atrial fibrillation with a thermocool® smarttouch® sf bi-directional nav catheter and suffered a cardiac tamponade requiring a pericardial drain.Initial transseptal puncture was noted to be anterior via ultrasound followed by an unspecified electrocardiogram change.Ultrasound revealed a small, dark area near the atrium and was assessed by the physician to be artifact (i.E.Misrepresentation or error).Second transseptal puncture was performed.Fast anatomical map (fam) was constructed.Right pvi was performed.Patient required increasing amounts of pharmacologic blood pressure support since the beginning of the procedure.During ablation phase, a tamponade was detected via ultrasound.Pericardial drain yielded 495 ml of fluid.Patient was reported to be in stable condition.Patient required one additional day of extended hospitalization as a result of the adverse event.Patient fully recovered.Factors cited that may have contributed to the adverse event include 2 anterior transseptal punctures.Physician¿s opinion regarding the cause of the adverse event was that it may have possibly been related to transseptal puncture.It was noted that the physician was uncertain as to when the injury occurred.Transseptal puncture was performed with a st.Jude medical brk transseptal needle.Sheath used was a st.Jude medical sl1.There is no information regarding generator parameters or generator settings.Ablation was stopped at 35 watts.Power was not titrated.Overall ablation time and last ablation cycle time at the site of injury were not reported, as the site of injury is unknown.Irrigated catheter flow was set on 17 ml/min.Patient received anticoagulant during the procedure with activated clotting time maintained at 350 seconds.There were no errors reported on any bwi equipment during the procedure.

• 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: 6639857
• MDR Text Key: 77537346
• Report Number: 9673241-2017-00468
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)170315(17)180227(10)17648306L
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17648306L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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: 59 YR