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 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The returned tubing was inspected; no visible damage was found.Irrigation test was performed and microbubbles were found in the tubing after flushing.These bubbles did not move during analysis.Alarm was not activated.Tube looked clear at the time of testing.("no flakes").A manufacturing record evaluation was performed for the finished device ac4976020 number, and no internal action related to the reported complaint was found during the review.The customer also provided a photo for investigation.Review of the photo revealed to be only of the shipping label and it does not show the tubing or the flakes reported by the customer.The complaint was not confirmed for "flakes" or any foreign material.Lab performed the irrigation test and confirmed the tubing failed to meet specification for the irrigation test.The issue was not related to manufacturing processes.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with smartablate¿ irrigation tubing set and a foreign material issue occurred.It initially reported by the customer that there were flakes inside the smartablate¿ irrigation tubing set.Several attempts to purge the tubing were done; however, the flakes remained.Although the customer¿s initial complaint was for flakes in the tubing, they also reported that attempts to flush the ¿flakes¿ out of the tubing were unsuccessful.Therefore, follow-up attempts were made to obtain additional information and/or a better description of the flakes in order to determine if the issue was a known cosmetic issue which has no safety or performance risks and is not considered to be mdr reportable.On 5/25/2020 additional information was received from the customer describing the issue only as a ¿material¿ with no movement and that the tubing was not used on the patient.As such, with the additional information provided, this event is being conservatively reassessed as foreign material inside the tubing and mdr reportable as a malfunction as of (b)(6) 2020.

Manufacturer Narrative

Additional information was received which indicates that the complaint device's manufacture date is 7/17/2019.This supplemental report has been updated accordingly in section h4.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

Manufacturer's reference number: (b)(4).On 9-mar-2022, an internal review of this file discovered this event was incorrectly reported to fda as a foreign material issue.However, the material was noted to be embedded or not moving and therefore does not pose a risk to the patient and therefore not considered to be an mdr reportable malfunction.As a result, the previously reported h6 medical device problem code for ¿device contamination with chemical or other material" (2944) no longer applies to this complaint.No further reports will be submitted for this event since this is no longer an mdr reportable event.

• 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): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10182472
• MDR Text Key: 198899059
• Report Number: 2029046-2020-00742
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/31/2022

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: 06/30/2020
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC4976020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/29/2020; 03/09/2022
• Supplement Dates FDA Received: 08/14/2020; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2019
• 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