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 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.Initial visual analysis determined the returned product appears to be in normal condition.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted to update the expiration date.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate¿ irrigation tubing set and ¿bubbles ¿ air in tubing¿ and ¿tubing set foreign material inside tubing¿ occurred.There were no patient consequences.While priming the tubing, prior to use on the patient, a bubble was observed.Customer was unable to remove the bubble.It was also noted that powder was observed inside the tubing.Tubing was changed and the issue resolved.Procedure was completed without patient consequences.The issue of ¿bubbles ¿ air in tubing¿ is not a reportable event.The issue of ¿foreign material inside the tubing¿ is considered a reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate irrigation tubing set and bubbles of air were observed in tubing along with foreign material inside the tubing.Product evaluation details: complaint product was inspected and it was found in normal condition.Irrigation test was performed and tubing pass specification.No foreign material.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.Complaint was not confirmed.The manufactured date and expiration date have been provided.Therefore, fields expiration date and device manufacture date have been populated.Manufacturer¿s ref # (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: 7701538
• MDR Text Key: 114425712
• Report Number: 2029046-2018-01808
• 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: 06/20/2018

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: 10/31/2018
• Device Catalogue Number: SAT001
• Device Lot Number: AC3947570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1