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); Injury (2348)

Event Date 10/12/2016

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 products: carto 3 system.(b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter and suffered a cardiac tamponade requiring pericardiocentesis.Prior to the procedure, a force sensor error (106) was noted when the catheter was connected.As a result, the catheter was replaced.At the end of the procedure, the tamponade was noticed on intracardiac echocardiogram, and the patient's blood pressure began to drop.A pericardiocentesis was performed, which stabilized the patient.The physician's opinion is that the cause of the injury was the procedure, specifically that it may have been a result of high force used at the contact point, but it is unknown when the injury occurred.There are no patient factors that may have contributed to the injury.There is no information regarding extended hospitalization.The patient's status has improved.A transseptal puncture was performed.The generator was being used in power control mode at 30 watts, though the temperature and impedance values are unknown.Also unknown are total ablation time at the site of the injury, catheter flow settings, sheath information, if anticoagulants were in use, spi values, and whether or not the catheter was in close proximity to another catheter at the time of the event.The catheter was zeroed after the initial warm up phase, but it is not known if the carto system indicated to re-zero it later.A force sensor error was noted when the catheter was first connected, but it was replaced and not used on the patient.The force sensor error demonstrates that the catheter is functioning as intended.Catheters exhibiting this failure mode cannot be used and must be replaced.The possibility that this could cause or contribute to a serious injury or death is remote.As such, this is not an mdr reportable finding.

Manufacturer Narrative

On 11/18/2016, the bwi failure analysis lab received the device for evaluation.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

The supplemental report sent 11/22/2016 stated that the device had been returned for analysis.However, additional information received states that the device has actually been disposed of.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.Manufacturer¿s reference number: (b)(4).

• 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: 6089797
• MDR Text Key: 59557504
• Report Number: 9673241-2016-00777
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(11)160414(17)170331(10)17446163L
• 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,Followup,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: D-1348-01-S
• Device Catalogue Number: D134801
• Device Lot Number: 17446163L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• 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): Life Threatening; Required Intervention