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 02/08/2018

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 idiopathic ventricular tachycardia procedure with a smartablate¿ irrigation tubing set and a film was visible on the inner lining of tubing.The issue was noticed after flushing the tubing.The substance was not embedded in the tubing it was on the inside of the tubing.No movement was observed.The foreign material was described as ¿very small, white in color and when observed up close resembles something like lint or lace¿.The smartablate tubing was replaced and the issue resolved.The procedure was completed with no patient consequence.This tubing set was never used on the patient.The foreign material observed is mdr reportable because it poses a potential risk to the patient.

Manufacturer Narrative

Additional information was received on march 1, 2018.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.Manufacturing date is 08/12/2017.Expiration date is 07/30/2018.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 05/08/2018.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a smartablate¿ irrigation tubing set and a film was visible on the inner lining of tubing.Upon receipt, the product was visually inspected and it was found in normal conditions.Flow testing was performed and product passed all specifications.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 could not be confirmed.Manufacturer's 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: 7308439
• MDR Text Key: 101589733
• Report Number: 2029046-2018-01284
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2018

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: 07/30/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3891604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 02/08/2018; 02/08/2018; 02/08/2018
• Supplement Dates FDA Received: 03/08/2018; 05/31/2018; 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1