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 Low Blood Pressure/ Hypotension (1914); Vasoconstriction (2126)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a female patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered coronary artery spasm and hypotension requiring a coronary angiogram (cag).Due to decreased blood pressure, the procedure was discontinued.Issue occurred during cavotricuspid ishmus (cti) ablation and after 3 hours since the procedure was started.As a result of performing cag, spasm was suspected.Nitro was administered and resolved.Patient¿s outcome from the adverse event was reported as fully recovered.The physician commented that ¿lack of relationship.¿ a smartablate¿ system rf generator was used during the procedure.

Manufacturer Narrative

It was reported that a female patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered coronary artery spasm and hypotension requiring a coronary angiogram (cag).Due to decreased blood pressure, the procedure was discontinued.Issue occurred during cavotricuspid ishmus (cti) ablation and after 3 hours since the procedure was started.As a result of performing cag, spasm was suspected.Nitro was administered and resolved.Patient¿s outcome from the adverse event was reported as fully recovered.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.The device investigation was completed on 26-jan-2022 which included a manufacturing record evaluation (mre).A manufacturing record evaluation was performed for the finished device 30604545l number, and no internal action related to the complaint was found during the review.The manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 12807512
• MDR Text Key: 285036404
• Report Number: 2029046-2021-01962
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30604545L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: CARTO3 EXTERNAL REFPATCH 6PACK; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female