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

Model Number SAT001

Device Problems Material Opacification (1426); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and a foreign powder adhesion was observed inside the tubing.Additionally, a temperature sensor error was observed.The smart touch sf catheter was replaced, and the issue resolved without patient consequence.The observed temperature sensor error is not reportable.The potential that it could cause or contribute to death, serious injury, or other significant adverse event is remote.The foreign powder observed in the tubing has been assessed as reportable.

Manufacturer Narrative

Additional information was received on 8/20/2018, indicating the manufacture date of 11/13/2017 and expiration date of 10/31/2018.Corresponding fields of this report have been updated.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacture ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and a foreign powder adhesion was observed inside the tubing.The bwi failure analysis lab received the device for evaluation on 8/20/2018.The investigational analysis has been completed.Upon receipt, the product was visually inspected and it was found in normal conditions.No powder or other foreign material was found in the tubing.Flow test performed and product passed all specification.No error or bubble found in tubing.Complaint was unable to duplicate.Manufacturer ref no: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4) per internal review on (b)(6)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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7748571
• MDR Text Key: 116061011
• Report Number: 2029046-2018-01910
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2022

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: 10/31/2018
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC3947579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/20/2018; 09/18/2018; 03/09/2022
• Supplement Dates FDA Received: 09/11/2018; 10/01/2018; 03/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1