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); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 05/01/2019

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.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.Manufacture ref no: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smart touch sf bi-directional navigation catheter and developed bradycardia, hypotension and st segment elevation requiring pacing.During the procedure, the patient became transient hypotensive, and developed bradycardia and st segment elevation.Pacing was performed.The issue resolved, and the case continued.The patient was reported in stable condition.There¿s no information regarding extended hospitalization or physician causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed bradycardia, hypotension and st segment elevation requiring pacing.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.Manufacture ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed bradycardia, hypotension and st segment elevation requiring pacing.Additional information was received on (b)(6) 2019, indicating a manufacturing record evaluation was performed and no internal actions were found during the review.In the initial, the concomitant product smartablate generator kit-us was omitted in error.The concomitant products section of this report has been updated with: cp-3981 smartablate generator kit-us.Additionally concomitant product cp-3336 smartablate pump kit-us was reported twice in error.Manufacture ref no: (b)(4).

• 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
• MDR Report Key: 8634648
• MDR Text Key: 145907641
• Report Number: 2029046-2019-03164
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30162683L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Required Intervention