MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING; 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 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/16/2018.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smartablate¿ irrigation tubing set, and when the tubing was connected to the saline and was flushed, bubbles were noticed and foreign material was found inside the tubing set.Loose and floating muddiness (suspended matter like dirt) was observed inside the tube.Flushing was performed before the tubing was used.No error code was observed on the irrigation pump.The device was replaced and the issue resolved with no patient consequence.The bubbles are not mdr reportable because bubbles in the tubing set can be an expected part of procedure set up, and flushing should be performed in order to remove the bubbles.However, the foreign material in the tubing is reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smartablate¿ irrigation tubing set, and when the tubing was connected to the saline and was flushed, bubbles were noticed and foreign material was found inside the tubing set.Additional information was received on 7/17/2018.The manufacturer date is 09/11/2017 and expiration date is 08/31/2018.The corresponding field of this report has been updated.The investigational analysis has been completed.The product was visually inspected and found to be in normal condition.No foreign material was found.Irrigation testing was performed and tubing passed specification.No micro bubbles were found in the tubing after flushing.The complaint was not confirmed.Manufacture ref no: (b)(4).

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7620544
• MDR Text Key: 112474260
• Report Number: 2029046-2018-01707
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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: 08/31/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3918186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1