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

Model Number D134805

Device Problems Image Orientation Incorrect (1305); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6)."no code available" is being used to represent the surgical intervention.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30401904m number, and no internal action 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the procedure after transseptal puncture, it was noticed that the orientation of the contact force (cf) vector of the stsf catheter was abnormal.No error message was displayed.It was confirmed by echocardiography that the catheter had entered between the right atrium and the left atrium septum.Cardiac tamponade was diagnosed and pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.Even though drainage was performed, the patient¿s blood pressure was not stable, and he went to thoracotomy.The physician commented that the issue did not occur because of the stsf usage and that it might have occurred due to the way the sheath was advanced during the transseptal puncture; however, no resistance was felt during the puncture.No bwi product malfunctions nor error messages were reported.Extended hospitalization was required.As of (b)(6), the patient was reported in stable condition and was planned to be discharged within that week.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this event is being conservatively reported under the stsf catheter because even though the issue have occurred during the transseptal puncture, the stsf catheter contact force vector was displayed incorrectly and the catheter had entered into a wrong place; therefore, the stsf catheter cannot be excluded.The incorrect force vector visualization, on its own, is not an mdr-reportable issue.However, since the cardiac tamponade is life threatening and required surgical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2020, bwi received additional information indicating that the patient was female.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10687597
• MDR Text Key: 211879113
• Report Number: 2029046-2020-01488
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30401904M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNK_TRANSEPTAL NEEDLE; UNSPECIFIED SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention