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

Model Number 301803M

Device Problems Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a preface® guiding sheath with multipurpose curve.It was reported that the dilator for the preface sheath was deformed at the hub.The medical team reported that there was an extra piece of plastic or "burr" at the hub.The dilator would not advance into the preface sheath.The preface sheath was replaced, and the issue resolved.The procedure continued.No patient consequences were reported.The issue was noticed before use--the sheath never entered body.The extra material on the dilator is still attached to dilator.The foreign material was blue like the dilator.The device was not used on the patient.Hub damage is not mdr-reportable.Foreign material on usable length of device is mdr-reportable.

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 reference number: (b)(4).

Manufacturer Narrative

On 24-apr-2023, the bwi product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 18-jul-2023, the product investigation was completed.It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a preface® guiding sheath with multipurpose curve.It was reported that the dilator for the preface sheath was deformed at the hub.The medical team reported that there was an extra piece of plastic or "burr" at the hub.The dilator would not advance into the preface sheath.The preface sheath was replaced, and the issue resolved.The procedure continued.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster for evaluation.And it was sent to cordis for further investigation.During visual inspection it was noted that the hemostasis valve/hub does not present any damages or anomalies.However, a flash was observed on the vessel dilator hub.Microscopic analysis: the vessel dilator was inspected with a vision system observing that presents evidence of elongations and plastic deformation on the torn area.Functional analysis: the water flowed through the parts and got out at the distal tip as expected, neither resistance to the water flow nor loose material was observed during the flushing procedure.A device history record evaluation was performed for finished device number 18146587, and no internal action related to the complaint was found during the review.The complaint reported by the customer was not confirmed, and no anomalies were observed in the hemostasis valve area and when during the insertion/withdrawal functional test.However, a torn condition and a kinked condition was observed on the vessel dilator hub.Exact cause of the observed damaged could not be conclusively determined during the analysis.Procedural/handling factors might have contributed to this issue.It seems that the material on the damaged area was affected with a sharp object and excessive force.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 16546748
• MDR Text Key: 311328238
• Report Number: 2029046-2023-00535
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2023

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: 18146587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 04/24/2023; 07/18/2023
• Supplement Dates FDA Received: 05/19/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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