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

Model Number	301803MS
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a hemostatic valve separation issue occurred.The valve cap broke off and was detached from the sheath at the beginning of the procedure.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did become detached from the sheath.The issue was noticed before any catheters were inserted into the sheath.No air entered the patient and this issue did not require percutaneous or surgical removal.The sheath was replaced and the issue resolved.The sheath is being returned along with the cap.The event was assessed as a mdr reportable hemostatic valve separation issue.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 17-nov-2021.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).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 03-jan-2022 a correction was observed on the 3500a initial under d 4.Expiration date as it was processed as 29-feb-2024.It should have been 31-dec-2023.Therefore, updated this field accordingly.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 13-feb-2022 the returned sample revealed the brim cap detached from the hub of the unit.The brim cap detached was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2022.Therefore, added under h6.Medical device problem code "detachment of device or device component a0501".The device evaluation was completed on 13-feb-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a hemostatic valve separation issue occurred.The valve cap broke off and was detached from the sheath at the beginning of the procedure.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did become detached from the sheath.The issue was noticed before any catheters were inserted into the sheath.No air entered the patient and this issue did not require percutaneous or surgical removal.The sheath was replaced and the issue resolved.The sheath is being returned along with the cap.The product was returned to biosense webster for evaluation.And it was sent to cardinal health for further investigation.Visual analysis of the returned sample revealed the brim cap was observed detached from the hub of the unit, as received.The complaint reported by the customer as ¿hemostatic valve ¿ separation¿ was confirmed since the brim cap was observed detached from the hub of the unit, as received.The brim cap was not return for its analysis.However, neither damages nor any anomalies were observed on the internal components of the hub.The cause of the detached brim cap observed on the unit could not be conclusively determined during the analysis; procedural factors and /or handling process may contribute to this issue.Controls are in place to verify the units for this kind issue; the produced devices are inspected 100% before leaving the facility.Several inspections are performed through all assembly process operations.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The root cause of the brim cap detached remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of 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 reference number: (b)(4).

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Common Device Name: 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12725758
• Report Number: 2029046-2021-01849
• Device Sequence Number: 4614188
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: 10846835000030
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K982740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/25/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 301803MS
• Device Catalogue Number: 301803MS
• Device Lot Number: 18009732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 01/03/2022; 02/13/2022
• Initial Report FDA Received Date: 10/31/2021
• Supplement Report FDA Received Date: 12/10/2021; 02/02/2022; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND SHEATH
• Patient Sex: Unknown