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 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture(s) were 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.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 female patient underwent an afib - paroxysmal ablation procedure with a preface® guiding sheath with multipurpose curve and a perforation of the dilator occurred.The dilator of the sheath (preface) was punctured by the transeptal needle (heartspan) during transeptal puncture.Surgery was delayed due to the reported event for 3 minutes.Action taken when event occurred was that preface sheath was replaced.Procedure was successfully completed.No fragments were generated.No patient consequences.The damage was identified through the fluoroscopic image and the sheath was withdrawn from inside the patient.

Manufacturer Narrative

It was reported that a female patient underwent an afib - paroxysmal ablation procedure with a preface® guiding sheath with multipurpose curve and a perforation of the dilator occurred.The dilator of the sheath (preface) was punctured by the transeptal needle (heartspan) during transeptal puncture.Surgery was delayed due to the reported event for 3 minutes.Action taken when event occurred was that preface sheath was replaced.Procedure was successfully completed.Device investigation details: a product photo was provided by the customer to aid in the investigation.The photo was sent to the device manufacturer for further investigation.Visual analysis of the returned sample revealed that the brim cap hub and the hemostasis valve were attached to the component, it was thoroughly inspected, and no anomalies were noted.Nevertheless, a kinked/bent condition was noted on the sheath, located approximately at 48.9 cm from distal tip.No other anomalies were noted.The customer reported complaint of damage to the vessel dilator was confirmed since the vessel dilator punctured with an apparent needle.The exact cause of the reported event could not be determined during the analysis of the picture, procedural factors and /or handling processes which may have contributed to this issue.Neither the product history record (phr) review nor the picture evaluation results suggest that the failure reported is related to the manufacturing process.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.Customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the video analysis results.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed the following items were inadvertently omitted from the 3500a initial medwatch report, "heartspan transeptal needle" and a "preface sheath", they have now been added.

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 3/8/2023, the product investigation was updated to process necessary corrections that were identified during an internal review.The following information has been removed from the investigation conclusion as it was not reflective of the evaluation performed.Please consider this statement removed from section h10.Additional manufacturer narrative of the 3500a supplemental (follow-up) #1: ¿visual analysis of the returned sample revealed that the brim cap hub and the hemostasis valve were attached to the component, it was thoroughly inspected, and no anomalies were noted.Nevertheless, a kinked/bent condition was noted on the sheath, located approximately at 48.9 cm from distal tip.No other anomalies were noted.¿ the corrected visual statement is: ¿per the picture received, it was noted that the vessel dilator is punctured with an apparent needle or a metallic tool.No other anomalies are noted.¿.

• 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: 15832049
• MDR Text Key: 304346761
• Report Number: 2029046-2022-02887
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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
• Report Date: 03/31/2023

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 Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 18107947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/20/2022
• Supplement Dates Manufacturer Received: 12/07/2022; 03/08/2023
• Supplement Dates FDA Received: 12/29/2022; 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTSPAN TRANSEPTAL NEEDLE.; PREFACE SHEATH.
• Patient Sex: Female