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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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 suffered hypotension requiring fluids, medication and an overnight stay in the intensive care unit (icu).During the procedure the patient had a drop in blood pressure, fluids and medication were administered to the patient.The patient's blood pressure dropped for the second time during the procedure and fluids and medication were once again administered to the patient.It was confirmed via echo ultrasound and contrast dye, that there was no effusion or injury to the patient.The physician was unable to confirm what the cause of the issue was.The patient was reported to be in stable condition and is currently being monitored in the icu.Upon follow up the patient condition was reported to be fully recovered and the patient was discharged home the next day.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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 suffered hypotension requiring fluids, medication and an overnight stay in the intensive care unit (icu).It was confirmed via echo ultrasound and contrast dye, that there was no effusion or injury to the patient.Upon follow up the patient condition was reported to be fully recovered and the patient was discharged home the next day.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Based on the reported event, several tests were performed.The magnetic, temperature, and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal action were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

Manufacturer's ref.# (b)(4) on 4/22/2021, during an internal review of this file, it was determined that the event should not have been assessed as mdr reportable against the thermocool® smart touch® sf bi-directional navigation catheter as there is insufficient information to consider the thermocool® smart touch® sf bi-directional navigation catheter related to the patient's hypotension.The event has been reassessed and the thermocool® smart touch® sf bi-directional navigation catheter is considered to be a concomitant device in this event and not mdr reportable.As such, the h 6.Medical device problem code field has been updated from patient device interaction problem (a01) to adverse event without identified device or use problem (a24).

• 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: 11429882
• MDR Text Key: 240655317
• Report Number: 2029046-2021-00307
• 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,Followup
• Report Date: 02/09/2021

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: 11/12/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30462741M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 03/17/2021; 04/22/2021
• Supplement Dates FDA Received: 03/17/2021; 04/09/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other