MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMART ABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number SAT001

Device Problems Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

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 an atrial fibrillation (afib) procedure with a smart ablate¿ irrigation tubing set and foreign material was found inside the tubing.Before the procedure, while the smart ablate tubing was being primed, there was powder inside and air bubbles could not be removed.The pump did not display any error message.The tubing was never used on the patient.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient's consequence.The bubbles in tubing is not reportable.However, the powder observed inside the tubing is a reportable issue.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 5/19/2018.Additional information was received on 6/1/2018.The expiration date (08/31/2018) and manufacturing date (9/11/2017) were provided.The corresponding fields of this report have been updated.Upon receipt, the product was visually inspected and it was found in normal conditions.Flow test performed and product passed all specifications.No error or bubbles were 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 not confirmed.Manufacturer's ref.No: (b)(4).

• Brand Name: SMART ABLATE¿ 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: 7514738
• MDR Text Key: 108372954
• Report Number: 2029046-2018-01549
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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: AC3918186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2018
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1