MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TUBING SET - FOREIGN MATERIAL INSIDE TUBING; 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 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Still pending is the expiration date and device history record (dhr).Therefore, a supplemental report will be submitted to update.Expiration date.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a smartablate¿ irrigation tubing set and when flushing was conducted, it was noticed that there was something like dust in the lumen of the tubing.The tubing was replaced to complete the procedure.No patient consequences were reported.The response received confirmed that the material did not have movement; however, the material was confirmed to be inside the tubing.Pictures of the foreign material are not available.The foreign material found inside the tubing was assessed as a reportable malfunction.

Manufacturer Narrative

The biosense webster inc.Failure analysis lab received the device for evaluation on 6/22/2018.The device history record and expiration date have been provided on 7/17/2018.Therefore, expiration date has been populated.Investigation summary: it was reported that a patient underwent a procedure with a smartablate¿ irrigation tubing set and when flushing was conducted, it was noticed that there was something like dust in the lumen of the tubing.The tubing was replaced to complete the procedure.No patient consequences were reported.The response received confirmed that the material did not have movement; however, the material was confirmed to be inside the tubing.Complaint product was inspected and it was found in normal condition.No foreign material found.Irrigation test was performed and the tubing passed specifications.No microbubbles were found in the tubing after flushing.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.Manufacturer's ref.No: (b)(4).

• Brand Name: TUBING SET - FOREIGN MATERIAL INSIDE TUBING
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7593931
• MDR Text Key: 110858146
• Report Number: 2029046-2018-01665
• 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: 05/22/2018

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: 08/31/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3918188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1