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

Model Number D134801

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

Patient Problems Perforation of Vessels (2135); No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered vessel perforation requiring surgical intervention.Pvi was completed and linear cauterization was performed on the cavotricuspid isthmus (cti).At that time, the catheter fell into the inferior vena cava (ivc) and punctured it.There¿s a possibility that the perforation become a cardiac tamponade.Open-chest surgery was required, and a hole was found in the ivc and was sutured.No infectious disease occurred.The patient was extubated on (b)(6) 2020.It is unknown if prolonged hospitalization was required.Patient¿s outcome is unknown.The physician commented the perforation to the ivc was caused by the ablation catheter when applying ablation to the cti.No bwi product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The cardiac tamponade is not being coded since it was suspected but not confirmed.In addition, there¿s no indication of effusion that needed to be drained by pericardiocentesis or pericardial window.Since the event is life threatening and required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6)2021, bwi received additional information regarding the reported event.The patient was a 61-year-old female.A manufacturing record evaluation was performed for the finished device 30427236m number, and no internal action was 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).

• 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: 10858768
• MDR Text Key: 217094592
• Report Number: 2029046-2020-01728
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30427236M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; LASSO NAV SPLITHANDLE; PENTARAY NAV; SMARTABLATE TUBING SET; SOUNDSTAR ECO CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR