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 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.Initial visual analysis identified the tube appears opaque but no foreign material found.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.Still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted.Expiration date.Manufactured date.Concomitant bwi products: thermocool® smart touch® sf bi-directional navigation catheter.(b)(6).(b)(4).

Event Description

It was reported a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ irrigation tubing set.It was reported that there was a magnetic sensor error while using the thermocool® smart touch® sf bi-directional navigation catheter.The catheter was replaced and the issue resolved.The issue of error message by the catheter is not a reportable issue.It was also reported that the smartablate¿ irrigation tubing set looked contaminated on the inside.The tubing set was replaced and the issue resolved.The procedure was completed without patient's consequence.The issue of foreign material inside the tubing is a reportable event.

Manufacturer Narrative

The manufactured date and expiration date have been provided.Therefore, expiration date and device manufacture date have been populated.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).

Manufacturer Narrative

It was also reported that the smartablate¿ irrigation tubing set looked contaminated on the inside.The tubing set was replaced and the issue resolved.The procedure was completed without patient's consequence.The issue of foreign material inside the tubing is a reportable event.Product evaluation details: upon receipt, the product was visually inspected and it was found in normal conditions.No foreign material was found in the tubing.Flow test performed, and product passed all specification.No error or bubble found in tubing.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 unable to duplicate.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: 7653282
• MDR Text Key: 112863448
• Report Number: 2029046-2018-01751
• 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,Followup
• Report Date: 06/08/2018

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: 09/30/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3947515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 07/30/2018
• Supplement Dates FDA Received: 07/27/2018; 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1