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 02/19/2018

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.Manufacturer's ref.No (b)(4).

Event Description

It was reported that a patient underwent a supraventricular tachycardia procedure with smartablate¿ irrigation tubing set and foreign material was observed in the tubing.Prior to use on the patient, the smartablate tubing was cloudy and seemed to have a foreign substance on the inside.The substance was white in color and made the tubing appear opaquer.The tubing was replaced and the issue resolved.The tubing was never used on the patient.The procedure was completed with no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent a supraventricular tachycardia procedure with smartablate¿ irrigation tubing set and foreign material was observed in the tubing.Upon receipt, the product was visually inspected and it was found in normal conditions.Flow test performed and product passed all specification.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 was unable to be confirmed.(b)(4).

Manufacturer Narrative

Additional information was received on april 24, 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.In addition, the manufacturing date is 08/08/2017 and the expiration date is 07/31/2018.Lastly, the bwi failure analysis lab received the device for evaluation on 05/14/2018.The analysis has begun but is not completed 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

This event was incorrectly assessed as a reportable event.This event is not mdr reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.However, since it has already been reported to fda, any additional updates received will continue to be reported accordingly.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: 7332302
• MDR Text Key: 102201368
• Report Number: 2029046-2018-01318
• 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: 02/19/2018

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: 07/31/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3831196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 02/19/2018; 02/19/2018; 11/19/2018
• Supplement Dates FDA Received: 05/15/2018; 06/21/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1