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

Model Number SAT001

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 9/30/2019.Initial visual analysis observed there was no visual damage or anomalies.The packaging was not returned with the product for evaluation.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.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.# (b)(4).

Event Description

It was reported a patient underwent an ablation procedure with a smartablate¿ irrigation tubing set and a sterilization issue occurred.It was reported that the inner packaging had a rupture and the sterilization of the smartablate¿ irrigation tubing set was compromised.The smartablate¿ irrigation tubing set was replaced and the issue resolved.The case continued.There were no patient consequences reported.

Manufacturer Narrative

It was reported a patient underwent an ablation procedure with a smartablate¿ irrigation tubing set and a sterilization issue occurred as the inner packaging had a rupture.The returned tubing was inspected, and no visible damage was found.Packaging, which was the main cause of the complaint, was not returned by the customer, hence an analysis of the pouch could not be conducted.Complaint cannot be confirmed without the pouch at hand.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.No: (b)(4).

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: 9154228
• MDR Text Key: 195369368
• Report Number: 2029046-2019-03718
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC4735056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2019
• 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