MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE¿ SYSTEM IRRIGATION PUMP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number M4900109

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation (mre) cannot be conducted because no lot/serial number was provided by the customer.(b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a using the martablate¿ system irrigation pump and an issue of undetected air bubbles occurred.It was reported that at the beginning of the procedure, the smartablate¿ irrigation tubing set was prepared according to the workflow and no bubbles were found in the tubing.The bubble alarm on the smartablate¿ system irrigation pump was not triggered.After a few minutes of ablating, the smartablate¿ system irrigation pump beeped and warned about bubbles in the system.The smartablate¿ irrigation tubing set was visually inspected and bubbles were found between the drip chamber and the smartablate¿ system irrigation pump.As such, the tubing was replaced and they allowed for the saline to flow through the new smartablate¿ irrigation tubing set; no bubbles were found in the new smartablate¿ irrigation tubing set.The smartablate¿ system irrigation pump alarm was not triggered by bubbles.At the end of the procedure, the tubing was visually inspected again, and some bubbles were found right after the drip chamber and the tubing had to be flushed again to remove the bubbles.There were no patient consequences.This event has been determined to be an mdr reportable malfunction since it was reported that the air bubbles might have passed through the smartablate¿ system irrigation pump sensor undetected.

Manufacturer Narrative

On 1/6/2020, additional information was received clarifying the pump used in the procedure was a smartablate¿ system irrigation pump with catalog # m4900109 and serial # (b)(6).As such, the following updates have been processed in each respective field: d2.Common device name changed from cardiac ablation percutaneous catheter to similar device m490008, pma # p990071/s017 d4.Catalog # changed from unk_smartablate pump to m4900109 d4.Serial # updated with (b)(6) d4.Unique identifier (udi) updated with (b)(4) g1.Manufacturing site name changed from biosense webster inc (juarez)f to biosense webster inc (irwindale) g1.Manufacturer site addr.Street line 1 changed from circuito interior norte to 15715 arrow highway g1.Manufacturer site addr.Street line 2 changed from 1820parque industrial salvacar to blank g1.Manufacturer site city changed from juarez to irwindale g1.Manufacturer site state code changed from blank to ca g1.Manufacturer site zip code changed from 32599 to 91706 g1.Manufacturer site country code changed from mex to usa additional information received on 1/6/2020 clarified that the bubbles observed in the new smartablate irrigation tubing set (lot: ac4997457) was not suspected to have the bubbles pass through the smartablate¿ system irrigation pump undetected.The bubbles were found right after the drip chamber and the tubing had to be flushed again.As such, no product malfunction should be suspected from the smartablate¿ system irrigation pump and this event will no longer be considered to be mdr reportable.Correction: it was also noticed that the concomitant products were inadvertently omitted from the 3500a initial mdr.They have now been added to section d11.Concomitant med.Products section.Manufacturer¿s ref # (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9534227
• MDR Text Key: 200061821
• Report Number: 2029046-2019-04082
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M4900109
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE IRR TUBE SET; SMARTABLATE IRR TUBE SET