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 04/18/2022

Event Type  Injury  

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 30706908l and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) female patient ((b)(6), 162cm) underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st elevations requiring a cardiac catheterization procedure with intervention, which showed coronary artery stenosis.The patient also required prolonged hospitalization.After the procedure started for one hour, st elevation was observed, therefore, a cardiac catheterization procedure was performed.Slight stenosis was confirmed.The patient recovered with administration of vasodilator after coronary angiogram (cag).A percutaneous coronary intervention (pci) was performed, and hospitalization was prolonged.St returned to normal, and the patient was unaffected, but the ablation procedure was discontinued.The physician considered that the event was unlikely related to bw product.The patient outcome of the adverse event was fully recovered.The patient¿s prognosis was stable, and the patient was discharged from the hospital on (b)(6) 2022.The generator used in the case was a smartablate.The adverse event was discovered during use of biosense webster products.The physician¿s opinion regarding the adverse event was that the possibility of a relationship with this product is low.The patient outcome of the adverse event was fully recovered.The generator used in the case was a smartablate (serial number unknown).

• 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 ; 646591-798
• MDR Report Key: 14437834
• MDR Text Key: 292049039
• Report Number: 2029046-2022-01059
• 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
• Report Date: 05/18/2022

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: 01/24/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30706908L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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; SOUNDSTAR ECO SMS 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG