MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE IRRIGATION 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 01/04/2018

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a smartablate irrigation tube set and foreign material was discovered.During the procedure, when the tubing set was taken from the package, foreign matter was contained in the tube.Priming was conducted but the issue continued.The issue was resolved by changing the tubing set to another one.This tubing set was not used on the patient.The procedure was completed with no patient consequence.This event is mdr reportable because if foreign material is found inside the tubing it poses a potential risk to the patient.

• Brand Name: SMARTABLATE IRRIGATION TUBE SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7242290
• MDR Text Key: 99327116
• Report Number: 2029046-2018-01149
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

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: 04/30/2018
• Device Catalogue Number: SAT001
• Device Lot Number: ACG63276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1