MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE IRRIGATION TUBE 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 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a smartablate irrigation tubing set where a powder-like foreign material was found inside the tube.The foreign material was noticed while priming the pump, prior to using the tubing set.Flushing did not remove the substance, so the tubing set was exchanged for a new one.The procedure was then continued without patient consequence.Foreign material inside the tubing presents a potential risk to the patient, making this event mdr reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 2/21/2018.The 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.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a procedure for atrial fibrillation with a smartablate irrigation tubing set where a powder-like foreign material was found inside the tube.The foreign material was noticed while priming the pump, prior to using the tubing set.Flushing did not remove the substance, so the tubing set was exchanged for a new one.The procedure was then continued without patient consequence product investigation: complaint product was inspected and it was found in normal condition.Irrigation test was performed and microbubbles were found in the tubing.The bubbles were attached to the tubing and were not moving.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.Foreign material was not confirmed.Microbubbles found in tubing.On 5/16/2018, additional information was received clarifying the event month was (b)(6).As such, a correction to date of event has been processed from (b)(6) 2017 to (b)(6) 2017.Manufacturer's ref # (b)(4).

• Brand Name: SMARTABLATE IRRIGATION TUBE 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7169946
• MDR Text Key: 97580045
• Report Number: 2029046-2018-01020
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: (01)10846835009743(11)170502(17)180331(10)ACG48479
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

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: 03/31/2018
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: ACG48479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/19/2017; 04/25/2018
• Supplement Dates FDA Received: 03/09/2018; 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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