MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a cardiac ablation procedure on (b)(6) 2018 with a thermocool smart touch sf bidirectional (stsf) catheter and developed bradycardia and hypotension requiring medication.During the procedure, the stsf catheter was used for ablation.Radio frequency (rf) of 115 applications was delivered.No device deficiencies were reported.The procedure was completed with no immediate patient consequences.On post-procedure day 0 ((b)(6) 2018), the patient developed bradycardia.An unspecified medication was administered.Extended hospitalization of (3 days) was required as a result of the event.The issue was then resolved.The principal investigator assessed this event as severe, serious, not related to the investigational device (stsf), not related to the study catheters, not related to the biosense webster inc.(bwi) non-investigational device and probable index procedure related.On post-procedure day 0 ((b)(6) 2018), the patient developed hypotension.An unspecified medication was administered.Extended hospitalization (3 days) was required as a result of the event.Issue was resolved.The principal investigator assessed this event as severe, serious, not related to the investigational device (stsf), not related to the study catheters, not related to the bwi non-investigational device and probable index procedure related.On post-procedure day 8 ((b)(6) 2018), the patient developed fatigue.An unspecified medication was administered.Extended hospitalization was not required.Issue was resolved.The principal investigator assessed this event as moderate in severity, not serious, not related to the investigational device (stsf), not related to the study catheters, not related to the bwi non-investigational device and possible index procedure related.Unrelated patient event: post-procedure day 15 ((b)(6) 2018), the patient developed bilateral lower extremity (ble) edema.The principal investigator assessed this event as moderate in severity, not serious, not related to the investigational device (stsf), not related to the study catheters, not related to the bwi non-investigational device and unlikely related to the index procedure; therefore, this event will not be coded or reported.

• Brand Name: THMCL SMTCH SF BID, TC, D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8888613
• MDR Text Key: 154395174
• Report Number: 2029046-2019-03542
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30077227L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR