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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pericardial Effusion (3271); Heart Block (4444)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30656621l 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 (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered heart block requiring a temporary pacemaker.During the procedure marked prolongation of p-q was observed in sinus after box isolation, therefore, temporary implantation of a pacemaker was performed.The procedure itself was completed without any problem.Bundle branch block and pef (believed to be referring to pericardial effusion) were confirmed from the time the patient entered the room.Follow-up after temporary implantation was performed.The physician commented that there was no causal relationship between this event and the product.Additional information was received on the event.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it is not related with the bwi product.The patient outcome of the adverse event was improved.The patient had a history of dialysis.Leg block and pef were confirmed from the time of admission.Additional 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 2-mar-2022.The physician commented that there is no causal relationship between this event and the mobicath smc guiding sheath concomitant product.Additional information was received on 3-mar-2022.The patient weighs 60 kg.The patient outcome is now fully recovered.The patient did not require extended hospitalization.Generator was provided.Therefore, added the generator information to the d 10.Concomitant medical products and therapy dates field and patient¿s weight under the fields a4.Weight of the patient and a 4.Weight unit.Additional information was received on 14-mar-2022.Leg block definition is related to bundle branch block and pef does not mean pericardial effusion.It means persistent atrial fibrillation.There was no pericardial effusion or cardiac tamponade and no steam pop.Therefore, removed h6.Health effect - clinical code the patient code of pericardial effusion.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; 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: 13653937
• MDR Text Key: 286465291
• Report Number: 2029046-2022-00431
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30656621L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2021
• 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: MOBICATH SMC GUIDING SHEATH.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE GEN. KIT (JAPAN).; SOUNDSTAR ECO SMS 8F CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 60 KG