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 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate¿ irrigation tubing set and while priming, unidentified foreign material was observed in the tubing set.Air bubbles were observed in the tube.Replacement of the tubing set resolved the issue.No adverse patient consequences were reported.The observed air bubbles in the tubing set has been assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The issue of foreign material in the tubing set has been assessed as reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate¿ irrigation tubing set and while priming, unidentified foreign material was observed in the tubing set.The biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation on 1/16/2019.The investigational analysis completed on 1/25/2019.Flow testing was performed and the product passed all specifications.No error or bubble found in tubing.Complaint lab was unable to duplicate failure.On 1/15/2019, 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.Manufacture reference 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: 8234656
• MDR Text Key: 132978456
• Report Number: 2029046-2019-02550
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: SAT001
• Device Lot Number: AC4222278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1