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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30410083m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient (male, (b)(6)) underwent cardiac ablation procedure for paroxysmal atrial fibrillation (paroxysmal supraventricular tachycardia) with thermocool® smart touch® sf bi-directional navigation catheter and suffered atrioventricular block requiring no intervention.The physician¿s commented that it was not an atrioventricular block created by a product defect.As of (b)(6) 2020 no pacemaker has been implanted, but a pacemaker may be implanted in the future.The event occurred post-use of biosense webster products.A day after the procedure, complete av block was discovered.But any medical or surgical intervention was not required and the hospitalization was extended for few days.The physician considered the cause of av block was not related to the biosense webster catheter.The patient¿s condition has improved.The patient had already been discharged from the hospital, and although there were no problems with riding a bicycle, etc., the patient reported that the patient had palpitations symptoms when going up the stairs.The ablation procedure was completed without any products problem.Since this event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

• 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11075188
• MDR Text Key: 223800063
• Report Number: 2029046-2020-01992
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 12/01/2020

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 Expiration Date: 07/30/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30410083M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; SMARTABLATE TUBING SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR