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

Model Number 301803M

Device Problems Material Perforation (2205); Device Handling Problem (3265)

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

Event Date 03/02/2023

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.Initial reporter phone:(b)(6).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 a paroxysmal atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and the needle exited the irrigation hole.It was reported that during the transseptal puncture process, the medical team found it very difficult to perform the puncture and advance the preface sheath through the septum.Removing the sheath from the patient, they found that the needle had made a new path at the tip of the sheath, with a hole just before the effective tip of the sheath, which was making puncture difficult.Therefore, they asked to exchange for a new sheath, and then the procedure proceeded normally and eventually successfully completed.No problems happened to the patient.There were no procedural delays.No fragments were generated.

Manufacturer Narrative

On 20-apr-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) on 31-mar-2023, the h6.Medical device problem code was corrected from device handling problem (a2301) to material perforation (a0410).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and the needle exited the irrigation hole.It was reported that during the transseptal puncture process, the medical team found it very difficult to perform the puncture and advance the preface sheath through the septum.Removing the sheath from the patient, they found that the needle had made a new path at the tip of the sheath, with a hole just before the effective tip of the sheath, which was making puncture difficult.Therefore, they asked to exchange for a new sheath, and then the procedure proceeded normally and eventually successfully completed.No problems happened to the patient.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and then it was sent to the manufacturer for further investigation.The evaluation has been completed.During visual inspection, the unit presents a puncture on the distal tip of the vessel dilator.The preface guiding sheath does not present any damage.An insertion/withdrawal test was performed using a gage to verify the diameter reduced distal tip (transition radial).The test was performed successfully.Additionally, on the images provided by the customer, the distal portion of the sheath and the vessel dilator inserted are observed.A possible puncture/cut is noted near the distal end/tip of the vessel dilator.No other anomalies were noted.The complaint reported by the customer was confirmed from the pictures since a puncture/cut was found on the distal end of the vessel dilator.However, the exact cause of the reported event could not be conclusively determined with the sole picture information since the device has not been returned.A device history record evaluation was performed and no internal actions related to the complaint was found during the review.The complaint reported by the customer was not confirmed from the product analysis, the insertion/withdrawal functional test was performed successfully.However, a puncture/cut was observed on the distal tip of the vessel dilator.The exact cause of the observed damage 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 from the inside toward the outside surface of the vessel dilator.Neither the product history review (phr) review nor the product analysis suggests that the observed damage could be related to the manufacturing process of the unit.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: the d4.Expiration date was previously reported as 30-jun-2025 which is incorrect.The correct expiration date is 25-jun-2025 and the field has been updated accordingly.

• 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: 16653004
• MDR Text Key: 312426594
• Report Number: 2029046-2023-00689
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 18123665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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
• Treatment: PREF.GUIDING SHEATH W/MULT.CRV.