MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE IRR TUBE 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 12/05/2018

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 during priming, foreign material was observed inside the tubing.Flush was conducted but it could not be removed.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient's consequence.No adverse patient consequences were reported.The observed foreign material in the tubing has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate¿ irrigation tubing set and during priming, foreign material was observed inside the tubing.The biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation on 1/10/2019 and no physical damage was observed.The investigational analysis completed on 1/18/2019.The smartablate¿ irrigation tubing set was inspected.No damage or foreign material was found.Irrigation testing was performed.Tubing passed all specifications.No micro bubbles were observed in the tubing after flushing.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Complaint was not confirmed.Manufacture reference no: (b)(4).

• Brand Name: SMARTABLATE IRR TUBE SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8220235
• MDR Text Key: 132592454
• Report Number: 2029046-2019-02533
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: SAT001
• Device Lot Number: AC4255659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1