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 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and before the procedure, when the tubing set was primed, a powdery material was observed inside the tubing.While priming the smartablate irrigation tubing, bubbles were also observed and could not be removed.No error code or alarm appeared.The tubing set was replaced and the issue resolved.Tubing was never used on the patient and no patient consequences were reported.Bubbles in tubing issue is not reportable.However, due to the presence of foreign material, this complaint has been assessed reportable.

Manufacturer Narrative

Additional information was received on 7/17/2018, indicating the manufacture date of 10/06/2017 and expiration date 9/30/2018.Corresponding fields of this report have been updated.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 bwi failure analysis lab received the device for evaluation on 8/3/2018.The analysis has begun but is not completed at this time.Manufacture ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and before the procedure, when the tubing set was primed, a powdery material was observed inside the tubing.Complaint product was inspected and it was found in normal condition.No foreign material found.Irrigation test was performed and tubing pass specification.No micro bubbles were found in the tubing after flushing.Complaint was not 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.Manufacturer ref no: (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: 7638949
• MDR Text Key: 112851797
• Report Number: 2029046-2018-01735
• 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,Followup
• Report Date: 05/31/2018

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: AC3926487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 05/31/2018
• Supplement Dates FDA Received: 08/08/2018; 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1