MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M490007

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Still pending is the manufactured date.Therefore, a supplemental report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia (at) procedure with a smartablate¿ system rf generator.The foot pedal got stuck and was not allowing to be released as the ablation would not stop while in the sheath and not the patient.The foot pedal had to be stepped on a few times to be released.No patient consequence was reported.The foot pedal getting stuck was assessed as a reportable issue.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial tachycardia (at)procedure with a smartablate¿ system rf generator.The foot pedal got stuck and was not allowing to be released as the ablation would not stop while in the sheath and not the patient.The foot pedal had to be stepped on a few times to be released.No patient consequence was reported.Defective foot pedal was disposed and new foot pedal was replaced.Issue was resolved and restored to specification.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.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: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9324484
• MDR Text Key: 195043239
• Report Number: 2029046-2019-03882
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M490007
• Device Catalogue Number: M490007
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1