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 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a smartablate¿ irrigation tubing set and a foreign material issue occurred.During set up for an ablation procedure, small white particles were observed in the smartablate tubing set.The tubing was flushed but the particles couldn't be removed.The tubing was changed, and the procedure was started without issues.No adverse patient consequences were reported.The observed foreign material has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a smartablate¿ irrigation tubing set and a foreign material issue occurred.During set up for an ablation procedure, small white particles were observed in the smartablate tubing set.On (b)(6)2019, additional information was received indicating that the small white particles observed in the smartablate tubing set appeared to look like bubbles, were ~0.5mm round, and embedded to the plastic of the tubing.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Manufacturer Narrative

During an internal review on 5/5/2020, it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with 4/30/2020 and section h4 manufacture date has been updated with 5/23/2019.Manufacture reference no: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).Per internal review on 9-mar-2022, it was identified that this event was incorrectly reported to the fda.The material was noted to be embedded or not moving and therefore does not pose a risk to the patient.As a result, the h6 medical device problem code was updated to "material opacification (a0409)".No further reports will be submitted for this 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: 9205589
• MDR Text Key: 195043222
• Report Number: 2029046-2019-03773
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC4878780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2019
• 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