MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1320-01-S

Device Problems Air Leak (1008); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

We are working on the device history record (dhr) and udi information.Once we get more information, it will be submitted in a supplemental.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a smartablate irrigation pump tubing set where microbubbles formed and a dark fluid was coming out of the tube.The microbubbles were causing an error on the irrigation pump, and during flushing, the dark liquid started to come out of the tube.The flushing did not resolve the issues, so the tubing set was replaced.A total of three replacement tubing sets were required before the issues were resolved.The case then continued without further issue.No patient consequences were reported.The presence of microbubbles is not reportable.Bubble errors on the irrigation pump are designed as a safety feature to prevent air from being introduced into the patient.The potential that this could cause or contribute to an adverse event is remote.The dark fluid being released from the tubing set is being conservatively treated as a foreign material.Foreign material inside the tubing set presents a risk of embolism or stroke.As a result, this event is mdr reportable.

Manufacturer Narrative

On 8/1/2017, a response was received from a bwi representative stating that no foreign material was observed inside the tubing.However, this event will still be conservatively considered mdr reportable based on the dark fluid coming from the tube during flushing.On 8/4/2017, the bwi failure analysis lab received the device for evaluation.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 reference number: (b)(4).Biosense webster manufacturer reference numbers (b)(4) are related to the same incident.

Manufacturer Narrative

On 8/24/2017, a device history record (dhr) review was performed.As a result, the manufacturing date, expiration date and udi fields have been updated.The device evaluation is still in progress.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent a procedure for atrial fibrillation with a smartablate irrigation pump tubing set where microbubbles formed and a dark fluid was coming out of the tube.The returned device was inspected, and was found in normal condition.And irrigation test was performed, and microbubbles were found in the tubing.The bubbles were attached to the tubing and were not moving.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.The customer complaint regarding the presence of microbubbles was confirmed.

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6751300
• MDR Text Key: 81512224
• Report Number: 2029046-2017-00242
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2017

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: 11/30/2017
• Device Model Number: D-1320-01-S
• Device Catalogue Number: SAT001
• Device Lot Number: OEM_D-1320-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 06/29/2017; 06/29/2017; 06/29/2017
• Supplement Dates FDA Received: 08/17/2017; 08/29/2017; 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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