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

Model Number 301803M

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a preface® guiding sheath with multipurpose curve, and a sheath perforation issue occurred.During the procedure, when the guide wire was inserted into the preface sheath, the hole at the tip was torn.Sheath replacement resolved the issue.The procedure was completed without patient consequence.The sheath perforation issue has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

On 6/23/2020, the product investigation was completed.It was reported that a patient underwent an ablation procedure with a preface® guiding sheath with multipurpose curve, and a sheath perforation issue occurred.During the procedure, when the guide wire was inserted into the preface sheath, the hole at the tip was torn.Sheath replacement resolved the issue.The procedure was completed without patient consequence.Device evaluation details: a non-sterile unit of product ¿pref guiding sheath: multi-shrt¿ was received for analysis inside of a clear plastic bag.Only the preface was returned.Product was unpacked and laid it on a tray in order to be evaluated.A kinked/bent condition was observed located at 57 cm from the distal tip.No damages or anomalies were noticed on the distal tip of the returned part.Dimensional analysis was performed to verify the correct cannula sheath id and od.The measurements were taken near to the accordioned condition in order to be verified versus the specification.Dimensional analysis results were found within specification.A product history review/manufacture record evaluation was performed and no internal actions related to the reported complaint were identified.The complaint regarding "the hole at the tip was torn" cannot confirmed.No damages or anomalies were observed on the distal tip.The root cause of the kinked/bent could be related to handling of the device during the procedure however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a preface® guiding sheath with multipurpose curve, and a sheath perforation issue occurred.The biosense webster inc.Product analysis lab received the device for evaluation.Upon initial inspection, no visual damage or anomalies observed.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference 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: 9649997
• MDR Text Key: 200082730
• Report Number: 2029046-2020-00159
• 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: 02/01/2020

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: 03/31/2022
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 17855356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2020
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 02/01/2020; 06/23/2020
• Supplement Dates FDA Received: 02/25/2020; 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1