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

Model Number SAT001

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978); Air/Gas in Device (4062)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a smartablate¿ irrigation tubing set.There was a crack in the tube and water leakage.There was a crack in the tube and water leakage occurred, the tubing was replaced and the issue resolved.Tubing defect bubble was confirmed by the overall including directly under the sensor and from upper to lower of pump.The procedure was successfully completed without patient's consequence.Bubbles in tubing is not mdr-reportable.Tubing set leakage is not mdr-reportable.Mid-procedure physical damage/crack on tubing is mdr-reportable.

Manufacturer Narrative

(b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 22-jul-2022, bwi received additional information indicating that the crack in the tubing set was found prior to use in patient.The physical damage was not caused an inaccurate flow rate during the procedure.Based on the additional information the event no longer constitutes a mid-procedure physical damage/crack on tubing.As the tubing problem is not a mid-procedure issue, the event is no longer mdr-reportable.No further reports will be sent regarding this event.Manufacturer reference number: (b)(4).

• 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 0000
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15048394
• MDR Text Key: 304028245
• Report Number: 2029046-2022-01648
• 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,Followup
• Report Date: 08/10/2022

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 Expiration Date: 10/31/2022
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC6814167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CARTO 3 SYSTEM; SOUNDSTAR