MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number SAT001

Device Problems Contamination /Decontamination Problem (2895); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The product investigation was completed.Device investigation details: the returned tubing was inspected, and no visible damage was found.Irrigation test was performed, tubing passed all specifications.No microbubbles were found in the tubing after flushing.Bubble alarm was not activated.Tube looked clear at the time of testing.Complaint was not confirmed.A manufacturing record evaluation was performed for the finished device number ac4656865 and no internal action related to the complaint was found during the review.Please note: an internal corrective action has been open for the issue of miscoding of events.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set.Before priming, there was white powder in the tubing and when primed, microbubbles occurred.Flush was conducted without resolution.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient's consequence.No further information is available.Bubbles/air in tubing is not mdr-reportable.Foreign material inside tubing set is mdr-reportable.

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 79906
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13955516
• MDR Text Key: 288486321
• Report Number: 2029046-2022-00677
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC4656865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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