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 Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

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 lot# 30356866m, and no internal actions 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.Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered a hypotensive episode requiring medication.After pulmonary vein isolation (pvi) and cavotricuspid isthmus (cti) ablations were completed a sudden drop in blood pressure of unknown cause occurred.The patient¿s blood pressure dropped to 50mmhg.Noradrenaline 1 cc was administered, and the patient recovered to the 100mmhg level.Absence of pericardial fluid was confirmed by intra-abdominal and surface echocardiograms.The physician¿s commented that cardiac tamponade was suspected but was confirmed to be absent.The opinion that it might be due to the consistency of blood vessels and responsiveness to drugs.The patient¿s outcome or extended hospitalization were not reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

On 10/4/2020, biosense webster inc.Received additional information about the patient and event.It was reported that the event occurred during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is patient condition.The patient fully recovered.The patient was male.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10469437
• MDR Text Key: 204967246
• Report Number: 2029046-2020-01136
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30356866M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JPN CARTO 3 SYSTEM; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Required Intervention