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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a perforation on the sheath occurred.It was reported that while preparing the preface® guiding sheath with multipurpose curve fixed introducer on the barren field for transseptal puncture, the dilator broke the inner lining of the introducer and comes out the distal end.There was no patient consequence.The introducer was changed.Additional information received indicates the device wasn't use on the patient.The problem was found during introducer preparation maneuvers, and it was chance before the transseptal puncture.There was no difficulty with the introducer preparation maneuvers.The material that came out of the distal end of the internal lumen was described as belonging to the internal part of the device.The procedure was successfully completed with a replacement device.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 28-apr-2023, it was noticed the following information was inadvertently omitted from section h10 the 3500a initial medwatch report: ¿the product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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 Narrative

On 31-may-2023, the bwi product analysis lab received the complaint device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a perforation on the sheath occurred.It was reported that while preparing the preface® guiding sheath with multipurpose curve fixed introducer on the barren field for transseptal puncture, the dilator broke the inner lining of the introducer and comes out the distal end.There was no patient consequence.The introducer was changed.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation.It was then sent to the manufacturer for further investigation.Visual and functional analyses of the returned device were performed following bwi procedures.One picture of the preface® guiding sheath with multipurpose curve was received for analysis.In the image, the distal portion of the sheath and the vessel dilator are observed.No damages on the components are noted.Then a visual inspection of the returned device revealed no signs of separation issues.However, it was observed that the polytetrafluorethylene (ptfe) was exposed.Also, neither the vessel dilator nor the guide wire presents any damages or anomalies.A microscopic analysis revealed that the ptfe had separated from the catheter wall.The issue is unrelated to the reported event.Upon further investigation, it was concluded that this issue was related to the manufacturing issue.Additional internal investigation was generated to address this issue.The complaint reported by the customer was not confirmed since the vessel dilator was not damaged, however, it was found that the ptfe was exposed at the distal tip.Product failure is multifactorial.A device history record evaluation was performed and no internal actions related to the complaint were found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) and manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: coating material (g04029) were selected as related to the exposed polytetrafluorethylene (ptfe) issue.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported perforation of the sheath.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16760741
• MDR Text Key: 313488319
• Report Number: 2029046-2023-00836
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 18139535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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