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

Catalog Number 301803M

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.We are working on the device history record (dhr) and udi information, once we get more information it will be submitted in a supplemental report.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a preface® guiding sheath with multipurpose curve and a hemostatic valve separation occurred.The preface sheath and smarttouch sf catheter were used for isolation the pulmonary vein.After completing the right pulmonary vein isolation, the sheath valve was loose and there was a small amount of reverse blood observed inside of the preface sheath.The left pulmonary vein isolation was in the second half and treatment was continued and finished.There were no other complications during ablation and after treatment.The procedure was completed with no patient consequence.If the hemostatic valve becomes detached/loose from the preface sheath, then it can cause an increase in bleeding, blood leakage or pose a potential risk to the patient.

Manufacturer Narrative

Additional information was received on march 8, 2018.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.Manufacturing date: 04/13/17.Expiration date: 03/31/2020.Corresponding fields have been updated.Manufacturer's ref.No: (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: 7298463
• MDR Text Key: 101166011
• Report Number: 2029046-2018-01273
• 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
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 301803M
• Device Lot Number: 17663006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1