MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Model Number 301803M

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a preface® guiding sheath with multipurpose curve and a thrombus issue occurred.During the ablation, thrombus was found at the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The same issue occurred with the preface® guiding sheath with multipurpose curve.The issues were resolved by replacing both devices and the procedure was completed without patient consequence.On 12/26/2019, biosense webster inc.(bwi) received additional information about the event.It was reported that the settings on the smartablate generator were set to the wrong setting by the medical engineer as non-irrigated 4mm catheter.After confirming the wrong setting, the physician removed the catheter and confirmed the thrombus.The issue was resolved by changing the devices.There was no report of patient consequence.The issue of thrombus formation on the devices has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a preface® guiding sheath with multipurpose curve and a thrombus issue occurred.During the ablation, thrombus was found at the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The same issue occurred with the preface® guiding sheath with multipurpose curve.The issues were resolved by replacing both devices and the procedure was completed without patient consequence.On 12/26/2019, biosense webster inc.(bwi) received additional information about the event.It was reported that the settings on the smartablate generator were set to the wrong setting by the medical engineer as non-irrigated 4mm catheter.After confirming the wrong setting, the physician removed the catheter and confirmed the thrombus.The issue was resolved by changing the devices.There was no report of patient consequence.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The vessel dilator was received fully inserted into the cannula sheath.Insertion/withdrawal test was successfully performed.The preface cannula sheath was well attached to the hub of the vessel dilator and successfully flushed.Neither resistance nor loosen material/matter was observed during the flushing procedure.Next, a lab sample guide wire was introduced through the vessel dilator, and the vessel dilator with the guide wire was successfully passed through the preface cannula sheath.No anomalies observed.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # pc-(b)(4).

Manufacturer Narrative

On 1/6/2020, the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.Initial visual analysis observed there was no visual physical damage or anomalies.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9533877
• MDR Text Key: 200061053
• Report Number: 2029046-2019-04081
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 17886772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1