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 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 12/20/2017.The initial visual inspection reveals the returned product appears normal with no visual damages or issues.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 when investigation is completed.  still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted to update the expiration date and manufactured date.(b)(4).

Event Description

It was reported that during an afib procedure, the smartablate¿ irrigation tubing set was primed and flushed, and then a bubble error occurred.The tubing was flushed several times but the issue continued.It was also reported that there was a powdery material adhered on the inside of the tubing.The issue was resolved by changing the tube to another one.The procedure was completed without patient consequences.The issue of "bubble error" is not reportable, however, the issue of "foreign material" is considered to be a reportable malfunction.

Manufacturer Narrative

It was reported that during an afib procedure, the smartablate¿ irrigation tubing set was primed and flushed, and then a bubble error occurred.The tubing was flushed several times but the issue continued.It was also reported that there was a powdery material adhered on the inside of the tubing.The issue was resolved by changing the tube to another one.The procedure was completed without patient consequences.The issue of "bubble error" is not reportable, however, the issue of "foreign material" is considered to be a reportable malfunction.Product evaluation summary: the returned complaint product was inspected and it was found in normal condition.No foreign material was found.An irrigation test was performed and microbubbles were found in the tubing.The bubbles were attached to the tubing and were not moving.Complaint was confirmed.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.The manufactured date and expiration date have been provided.Therefore, expiration date and device manufacture date have been populated.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: 7360281
• MDR Text Key: 103413924
• Report Number: 2029046-2018-01348
• 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: 10/18/2017

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: 01/31/2018
• Device Catalogue Number: SAT001
• Device Lot Number: ACG26057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1