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

Catalog Number SAT001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.¿s (bwi) failure analysis lab (fal) received two irrigation tubing sets of the same lot number for evaluation on 12/20/2018.Initial visual analysis for one of the smartablate¿ irrigation tubing sets indicates, ¿no physical damage was observed upon initial visual inspection.Original packaging returned open and damp.Tube appears to have been already flushed.¿ the initial visual analysis for the second returned smartablate¿ irrigation tubing sets indicates, ¿no physical damage was observed upon initial visual inspection.Original packaging not returned.Tube appears to have been already flushed.¿ additional follow up is being done to clarify the failure mode for each returned smartablate¿ irrigation tubing sets.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.Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and foreign material was found inside the packaging.It was reported that after smartablate¿ irrigation tubing set #1 was taken from the package and while priming was being conducted, there were bubbles that could not be removed.The tubing set was exchanged for smartablate¿ irrigation tubing set # 2.Prior to opening the smartablate¿ irrigation tubing set #2, the inside of the packaging was found with what appeared to be a white haze inside; therefore, the tubing set was not opened.This tubing set was exchanged for smartablate¿ irrigation tubing set # 3.The procedure was continued and completed without patient consequence.The issue of bubbles in the tubing set is not mdr reportable since the issue occurred during priming and not during use on patient.Additionally, bubbles in the tubing can be an expected part of procedure set up, and flushing should be performed in order to remove the bubbles.A safety feature of the pump is in place in order to stop flow if air is detected.However, the reported issue of foreign material (white haze) inside the packaging is considered mdr reportable.It was later reported the bubbles issue did not occur during priming.The customer did flush the tubing before using in the patient and the customer did notice the bubbles during the flow movement.The bubbles were not detected after passing through the pump sensor and therefore the pump did not provide any error messages.Additional follow up is being done to clarify the reported information.If additional information is received regarding clarifications requested for this event, a supplemental 3500a report will be submitted.

Manufacturer Narrative

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and foreign material was found inside the packaging.The inside of the packaging was found with what appeared to be a white haze inside; therefore, the tubing set was not opened.This tubing set was exchanged for another smartablate¿ irrigation tubing set.The procedure was continued and completed without patient consequence.Device evaluation details: the device evaluation has been completed.The complaint product was inspected and found cloudy.The cloudiness was related to tubing material.Irrigation test was performed and tubing pass specification with cloudy tubing.No microbubbles were found in the tubing after flushing.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.Complaint was confirmed.Manufacturer¿s ref # (b)(4).

• 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
• MDR Report Key: 8187710
• MDR Text Key: 131925159
• Report Number: 2029046-2018-02476
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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: 03/31/2019
• Device Catalogue Number: SAT001
• Device Lot Number: AC4222278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1