MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); No Code Available (3191)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) year old male patient underwent a right sided atypical atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed sinus bradycardia requiring surgical intervention.Towards the end of the procedure, post use of biosense webster products, after finishing the ablation line, and coming off coronary sinus pacing for blood pressure and stability, the patient's electrical signals for the sa node were slow to come back intrinsically.In addition, it was also noticed that the posterior and anterior sides of the superior vena cava had scar tissue.The physician used intracardiac echocardiogram to check for an effusion, and it was confirmed that no effusion was present.The slow sa node firing was confirmed by electrocardiograms.A permanent pacemaker was implanted.The patient was reported to be in stable condition.Extended hospitalization was not required as a result of the event.Physician¿s opinion regarding the cause of the event is that it is patient condition related.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9325193
• MDR Text Key: 178578722
• Report Number: 2029046-2019-03884
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Physician
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 74 YR