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 Cardiac Tamponade (2226)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.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 30287202m number, and no internal actions related to the complaint was found during the review.Product complaint # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheters and the patient suffered a cardiac tamponade.Approximately one to two hours of catheter use, during cavotricuspid isthmus (cti) linear and right pulmonary vein ablation, the contact force showed as ¿n/a¿ frequently and ablation could not be conducted.The catheter was pulled out and re-zeroed.The cable was changed without resolution; therefore, the catheter was changed, and the issue resolved.Immediately after replacing the first catheter, the second catheter contact force was showing abnormally high of 50g when ablation was going to be conducted.Ablation could not be conducted due to the high force reading.Cardiac tamponade was then discovered, and the procedure was stopped.The physician commented that the adverse event is possibly due to perforation during cavotricuspid isthmus (cti) ablation.There¿s no information regarding medical or surgical intervention, extended hospitalization or patient¿s outcome.The no force and high force issues were assessed as not mdr reportable events, as this is highly detectable when occurring.The potential that they could cause or contribute to a death, serious injury, or other significant adverse event is low.Since there is no clear indication which catheter might have contributed to the event, the patient event will be conservatively reported under the last ablation catheter used before the patient event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on (b)(6)2020 and it was reported that the patient was a female, therefore section 3.Sex has been populated.It was also reported that a pericardiocentesis was performed to drain the fluid (unspecified amount) from the pericardial space, therefore section b2.Is required intervention, has been selected.Additionally, on (b)(6)2020 , the biosense webster, inc.Product analysis lab received the device for evaluation.It was noted that upon initial visual inspection, there was no damage or anomalies observed.Investigation summary - the device was visually inspected, and it was found in good condition.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30287202m number, and no internal actions related to the complaint was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer's reference # (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: 9531980
• MDR Text Key: 188858885
• Report Number: 2029046-2019-04068
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30287202M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Life Threatening; Required Intervention