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 Stenosis (2263); Ischemic Heart Disease (2493)

Event Date 03/11/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered coronary artery stenosis and st elevation requiring intervention.It was reported that the patient had coronary artery stenosis.The sheath was removed at the end of the procedure.Electrocardiography showed st elevation, and percutaneous coronary intervention (pci) was performed because the right coronary artery was occluded.The physician commented that the event is not related to the product.The complaint product will not be returned for analysis.There were no problems with the product.Additional information was received on 22-mar-2022.It was reported that 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 was not related with the bwi product malfunction.A smartablate generator was used.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 number 30698007l and no internal action related to the complaint was found during the review.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 19-apr-2022.The patient outcome of the adverse event was unchanged.The physician¿s name was provided.Therefore, e1.Initial reporter title, e1.Initial reporter first name, e1.Initial reporter last name, e2.Health professional, and e3.Initial reporter occupation were updated.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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14059295
• MDR Text Key: 290785769
• Report Number: 2029046-2022-00760
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

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: 12/17/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30698007L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2.; UNK BRAND SHEATH.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male