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

Model Number D-1327-01-S

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problems Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

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 17509386m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Concomitant products that used in this study: uls soundstar and ring lasso2015nav.Other companies¿ device were used in this study: ab cardiolab, stim nihon koden, eco vivid, ring optima11-20, cs beeat, ra ibi10p.(b)(4).

Event Description

This complaint is from a literature source: a conference abstract of ¿catheter ablation sapporo 2017¿ in japanese.It was reported that one (b)(6) male patient with paroxysmal atrial fibrillation underwent radiofrequency ablation procedure using smarttouch ablation catheter on (b)(6) 2016.Patient had heavily symptomatic atrial fibrillation attacks frequently since (b)(6) 2016.Due to asa and the volume of the left atrium were small, it was difficult to have septal puncture.A right atrium contrast was added and it was successfully punctured with the catheter inserted into the left atrium.During bilateral pulmonary venous isolation, blood pressure dropped, infusion solution and noradrenaline administration were required.No observation of cardiac tamponade but anemia and fluid retention in the right thoracic cavity were confirmed.Right thoracic drainage and emergency right thoracotomy to provide hemostatic status were performed.Procedure was completed.It was inferred that the bleeding point was between the parietal wall and the left atrium and hemorrhage was done by suturing.Patient was recovered and discharged after six months' hospitalization.The physician commented that it was a small left atrial volume in cases of pulmonary disease complicated atrial fibrillation.As with asa, it was suspected the event was due to the septal puncture needle (japan lifeline) through the left atrioventral wall into the right thoracic cavity.The cause of the compilation was that the procedure was continued without confirmation by eco.

Manufacturer Narrative

Additional information was received on 07/13/2017 indicating that the title of this abstract is "a case which occurred right pleural effusion as a complication during af ablation".The author is tomoaki nakano.(b)(4).

• 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: 6710790
• MDR Text Key: 79955873
• Report Number: 9673241-2017-00570
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: (01)10846835009163(11)160707(17)170630(10)17509386M
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: D-1327-01-S
• Device Catalogue Number: D132701
• Device Lot Number: 17509386M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2016
• 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; Required Intervention
• Patient Age: 69 YR