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 05/25/2018

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 during the procedure, when the tubing set was primed, a powdery material was observed.The tubing set was replaced and the issue resolved.Tubing was never used on the patient and no patient consequences were reported.Multiple attempts have been made to gain clarification on this event with no response.There¿s no information on if the ¿powdery form¿ mentioned on the event description was inside or outside the tubing set.Therefore, this event will be conservatively reported as a foreign material found on the inside of the tubing.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and during the procedure, when the tubing set was primed, a powdery material was observed.Additional information was received on 7/17/2018, indicating the manufacture date of 10/02/2017 and the expiration date of 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 investigational analysis has been completed.The product was visually inspected and it was found to be in normal conditions.Flow testing was performed and the product passed all specifications.No error or bubble was found in tubing.Complaint was unable to duplicate.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: 7638519
• MDR Text Key: 112849524
• Report Number: 2029046-2018-01734
• 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: 05/31/2018

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: AC3924350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 08/15/2018
• Patient Sequence Number: 1