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

Catalog Number D132705

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

Patient Problem Cardiac Tamponade (2226)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device with lot number 30277450m, and no internal actions related to the reported complaint condition were identified.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) year-old-male patient underwent a paroxysmal atrial fibrillation ablation procedure with thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.The tamponade was discovered following isolation of the left pulmonary vein.Too much force applied inside appendage might be an explanation.Screen turned red to alert the physician and the sales rep repeated 4 times to be careful and to stop because force was too high.Force went up to 70g.Patient was drained correctly and fully recovered.During procedure, power mode was used with recommended irrigation flow.25w was used on post wall, 30w was used on the roof and 35w on the ridge.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information becomes available in the future; the reportability decision will be reassessed.The customer¿s reported issue of high force is not mdr reportable since the issue is highly detectable when occurring.

Manufacturer Narrative

On 12/24/2019, biosense webster inc.Received additional information about the event.It was reported that transseptal puncture was performed with an abbot sl0 sheath and abbot brk xs transseptal needle.There was no evidence of steam pop during the ablation.There was no evidence of steam pop during the ablation.The catheter irrigation was set at 17cc while applying <30 watts and 30 cc while applying >35 watts.The force visualization features used included graph, dashboard, vector and visitag.The parameters for stability used with the visitag module were reported ablation index, force over time 25% greater than 3 grams, tag size 2.5mm and ¿350 post and 420 ant." color options included force time interval (fti), average, force and time.No additional visitag filter was used.Additionally, the patient was reportedly in a car accident while on his way to the hospital 2 days prior to his surgery.No injuries were sustained.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 9528264
• MDR Text Key: 188858550
• Report Number: 2029046-2019-04073
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Catalogue Number: D132705
• Device Lot Number: 30277450M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOT BRK XS TRANSSEPTAL NEEDLE; ABBOT SL0 SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR