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

Model Number SAT001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

Still pending is the manufacturer record evaluation.Therefore, a supplemental report will be submitted.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and an occlusion with foreign material occurred.It was reported that during the procedure, while priming, something was stuck at the end of the tube and the priming failed.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient's consequence.The issue of foreign material occluding the irrigation tubing has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 7/19/2019.Initial visual analysis observed there was no visual damage or anomalies.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.  manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and an occlusion with foreign material occurred.It was reported that during the procedure, while priming, something was stuck at the end of the tube and the priming failed.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient's consequence.Device evaluation details: the device evaluation has been completed.Upon receipt, the product was visually inspected and no damage or anomalies were found.There was no occlusion and no foreign material were found.Flow test performed and product passed all specification.No error or bubble found in tubing.The device is working properly.Complaint was not confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.Manufacturer¿s ref # pc-000482069.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) per internal review on(b)(6)-2022, the manufacturing site name and address have been updated to reflect lake region medical.All the appropriate fields in section g.All manufacturers have been updated accordingly.

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8747115
• MDR Text Key: 150168227
• Report Number: 2029046-2019-03370
• 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,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC4480183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2018
• 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