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

Model Number D134805

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

Patient Problems Complete Heart Block (2627); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30420054m 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 underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered complete atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).The patient had high bundle branch and left anterior ventricular block going into the procedure.While mapping a second pvc on the left side and after had ablated the right ventricle outflow tract (rvot), they went retrograde in the aorta and flipped over the cusp when the shaft of the catheter maty have hit the his system.The patient went into a complete av block.No ablation was done to the his system.A temporary pacemaker was implanted, and the patient was monitored overnight.The patient was reported in stable condition.There¿s no indication that prolonged hospitalization was required.Physician¿s causality opinion was not provided.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• 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: 10826028
• MDR Text Key: 216616513
• Report Number: 2029046-2020-01677
• 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: Other
• Type of Report: Initial
• Report Date: 10/14/2020

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: 08/18/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30420054M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2020
• 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
• Patient Outcome(s): Required Intervention