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

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 12/01/2021

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 30656768l 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

During a clinical trial, it was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and on (b)(6) 2021 the patient suffered a retroperitoneal bleeding right side.Initially the event was assessed as bleeding.Event start date (b)(6) 2021.The severity was reported as severe.The adverse event was considered serious and the patient did not die.The event was assessed as life-threatening and did not result in a permanent impairment of a body structure or a body function.No in-patient or prolongation hospitalization was required.No medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function was performed.The study investigator stated the relationship to study device was not related and the relationship to the procedure was probable.The patient received medication but no surgery or other intervention.No device malfunction occurred, patient outcome was reported as not recovered/not resolved.Additional information was received on 07-dec-2021.The end date was (b)(6) 2021.The severity was reported as moderate.The event was not considered life-threatening.The relationship to the procedure was possible.Patient outcome was reported as recovered/resolved.The event was assessed as not mdr reportable.It was not life threatening; did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.Additional information was received on 20-dec-2021 stating erythrocytes concentrate was given.Additional information was received on 12-jan-2022 updating the adverse event from bleeding to retroperitoneal bleeding right side.Based on the information received on 20-dec-2021 that erythrocytes concentrate was given (blood transfusion), it was assessed that medical intervention was provided and therefore, this event was re-assessed to a serious injury.The awareness date for this reportable adverse event is 20-dec-2021.

Manufacturer Narrative

Additional information was received on 01-mar-2022.The retroperitoneal bleeding right side event was updated from unexpected/unanticipated to expected/anticipated.An additional event of thrombosis was provided.Thrombosis of right vena femoralis comm.Post puncture.Admission date: (b)(6) 2022.Event start date: (b)(6) 2022.The relationship to study device was considered not related and the relationship to study procedure was a causal relationship.The severity was moderate.The adverse event is serious.No death reported.Site awareness date: (b)(6) 2022.Date of index procedure: (b)(6) 2021.Not a life-threatening illness or injury.Not a permanent impairment of a body structure or a body function including chronic disease.In-patient or prolongation hospitalization reported.Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function was not required.The event is related to repeat/retreatment; (b)(6) 2022.Unknown medication was given.No cardioversion was performed.It was not a re-ablation procedure.No surgery was performed.No other intervention provided.Therefore, processed b2.Is hospitalization initial/prolonged, h 6.Health effect - clinical code and h 6.Health effect - impact code.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Under the retroperitoneal bleeding right side event it was originally reported as, ¿no in-patient or prolongation hospitalization was required.Additional information was received on 26-jul-2022 stating, ¿in-patient or prolongation hospitalization was required, admit date (b)(6) 2021 and discharge date was (b)(6) 2021.¿ if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Originally non bwi-agilis sheath was reported as a concomitant product.Additional information was received on 09-jan-2023 stating that this device was inactivated.Therefore, removed from concomitant products.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 UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13261714
• MDR Text Key: 284350285
• Report Number: 2029046-2022-00099
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30656768L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,12P SPLITHANDLE.; NGEN RF GENERATOR.; NON BWI-AGILIS SHEATH.; UNK_CARTO 3.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male