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

Catalog Number	M490008
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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).
Additional 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).
Additional 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)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9264053
• Report Number: 2029046-2019-03832
• Device Sequence Number: 2055067
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: M490008
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 11/07/2019; 12/17/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/20/2019; 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE IRR TUBE SET.