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 02/16/2018

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.Fda report no.'s 2029046-2018-01322 / 2029046-2018-01323 / 2029046-2018-01324 / 2029046-2018-01325 / 2029046-2018-01326 are related to the same incident.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with five smartablate¿ irrigation tubing sets and foreign material was seen inside the tubing.When the tubing set was pulled out of the box, white powder and cloudiness was seen inside 5 of the tubing sets (quantity 4 of lot# ac3812842 and quantity 1 of lot# ac3771497).The tubings were not opened or used on the patient.Another tubing set was used.The procedure was completed with no patient consequence.All tubing sets will be reported individually.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 04/13/2018.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

It was reported that a patient underwent an atrial fibrillation procedure with a smartablate¿ irrigation tubing sets and foreign material was seen inside the tubing.Complaint product was inspected and it was found in normal condition.Irrigation test was performed and microbubbles were found in the tubing.No foreign material was found.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.Microbubbles found in the tubing was unrelated to the complaint of white powder.Complaint was not confirmed.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

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: 7335922
• MDR Text Key: 102581233
• Report Number: 2029046-2018-01324
• 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,Followup,Followup
• Report Date: 02/16/2018

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: 05/31/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3812842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/16/2018; 02/16/2018; 02/16/2018
• Supplement Dates FDA Received: 05/01/2018; 07/18/2018; 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1