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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stenosis (2263); Ischemic Heart Disease (2493); Heart Block (4444)

Event Date 12/22/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered st segment elevation requiring coronary artery angiography and treatment.It was reported that after completing isolation around the left pulmonary vein (lpv), when they tried to exit pace and rp ablation with the ablation catheter, st elevation occurred, resulting in spasm.Blood pressure also decreased.Coronary artery angiography (cag) was performed, and norad and nicoranjel were inserted, and ablation was completed.Cag was performed to confirm that the right coronary artery was clogged.After that, nicoranjel was administered to resolve the spasm.However, blood pressure was also decreased, so noradrenaline was administered to maintain blood pressure.The physician commented that the opinion that it is not related to the product.Detailed status at the time of occurrence: after the lpv has been isolated once, when exit pace is performed in the ablation catheter and the right pulmonary vein (rpv) is energized, st rises, and spasm occurs.Blood pressure also dropped.They performed cag, add norad and nicolangel, and the ablation was completed.[progress]: performed cag and confirmed that the right coronary artery was blocked.After that, nikolangel was administered to eliminate spasm.However, since blood pressure was also decreasing, noradrenaline was administered to maintain blood pressure.Put as temporary and observed, if the block is not solved, the pacemaker will be inserted.Currently the patient is safe.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or 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

Initial reporter phone: (b)(6).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 30648218l 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).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13273832
• MDR Text Key: 288366232
• Report Number: 2029046-2022-00102
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30648218L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV SPLITHANDLE; PENTARAY NAV ECO; PREFACE GUIDING SHEATH; SOUNDSTAR ECO
• Patient Outcome(s): Required Intervention; Life Threatening