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

Catalog Number M490008

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

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 to update.Manufactured date.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal procedure with a smartablate¿ system irrigation pump (us) and ¿air bubbles undetected¿ event occurred.It was reported that there were bubbles observed in the smartablate¿ irrigation tubing set that were not caught by the smartablate¿ system irrigation pump (us) bubble sensors.The physician noticed them floating downstream close to the catheter hub.The stopcock was immediately turned off to the patient/catheter.The smartablate¿ irrigation tubing set was flushed several times using highest flow setting, but the flushing was unsuccessful to remove the bubbles.The smartablate¿ irrigation tubing set was exchanged and the procedure was completed without patient consequences.The bubble issue described in the event was assessed as not reportable.Bubbles in the tubing set can be an expected part of procedure set up, and flushing should be performed in order to remove the bubbles.A safety feature of the pump is in place in order to stop flow if air is detected.The issue of the air bubbles being undetected by the pump as no error message or alarm was generated by the pump was assessed as a reportable malfunction under the pump.

Manufacturer Narrative

On 10/31/2019, it was noticed that the concomitant product was inadvertently omitted from the 3500a initial mdr submitted to fda on 10/31/2019.The product has now been added to concomitant med products.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Initially it was reported that there were bubbles observed in the smartablate¿ irrigation tubing set that were not caught by the smartablate¿ system irrigation pump (us) bubble sensors.However, additional information was received on (b)(6)2019 and it was reported that the pump bubble sensor did initially detect the bubbles and that they were seen downstream as well.It was also reported that the pump has been operating normally, as the same pump was used since the original complaint and no other issues have been reported.Service was declined.Since the pump bubble sensor did initially detect the bubbles, this event was reassessed as not reportable.However, since it as already been reported to the fda, any additional updates received will continue to be reported.Additionally, on (b)(6)2018 , the date of manufacture for the smartablate¿ system irrigation pump (us) was received indicating the date of manufacture was (b)(6)2019 , therefore, device manufacture date.Device manufacture date has been populated.Also, on (b)(6)2019 , the certificate of conformance (coc) was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference #(b)(4).

Manufacturer Narrative

Correction: there was a typo in the h10.Addnl.Manf.Narrative/corrctve data of the supplemental 3500a report submitted on(b)(6)2019.The typo is to be corrected from ¿(b)(6)2018 ¿ to ¿(b)(6)2019 ¿.Correction: h6.Method codes, h6.Result codes, and h6.Conclusion codes were inadvertently omitted in the supplemental 3500a submitted on (b)(6)2019.The following codes have now been added: h6.Method codes ¿analysis of production records (3331)¿ and ¿device not returned (4114)¿, h6.Result codes ¿no findings available (3221)¿, and h6.Conclusion codes ¿no problem detected (67)¿.Manufacturer's reference # pc-000573815.

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9264053
• MDR Text Key: 191817021
• Report Number: 2029046-2019-03832
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• 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,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M490008
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE IRR TUBE SET.