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

Model Number	301803MS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was requested to clarify the concomitant product as the event states a second catheter was used to complete the procedure.Requesting if it should state, "a second sheath was used to complete the procedure." however, no further information has been made available.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's reference number: (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 hub detachment issue occurred.During the procedure, the component fell off.Component was separated from sheath.A second catheter was used to complete the procedure.There was no patient consequence reported.Additional information was received stating that the sheath was not being used on the patient.The event was assessed as mdr reportable for a hub detachment issue.
Additional Manufacturer Narrative
In the 3500a initial under h10.Additional manufacturer narrative, we reported the following: additional information was requested to clarify the concomitant product as the event states a second catheter was used to complete the procedure.Requesting if it should state, "a second sheath was used to complete the procedure." however, no further information has been made available.Additional information was received on 15-feb-2022 stating, ¿a second sheath was used to solve the problem.¿ therefore, processed d10.Concomitant medical products and therapy dates section.The bwi product analysis lab received the device for evaluation on 25-feb-2022.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) initially it was reported that a hub detachment issue occurred.However, after an internal review on 05-jul-2022, a correction was noted as it should have stated that a brim cap detachment occurred.The ¿h6.Medical device problem code¿ of ¿detachment of device or device component (a0501)¿ remains the same code.
Additional Manufacturer Narrative
The investigation was completed on 13-jul-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a brim cap detachment issue occurred.During the procedure, the component fell off.Component was separated from sheath.A second sheath was used to solve the problem.There was no patient consequence reported.Additional information was received stating that the sheath was not being used on the patient.The device photo was sent to the device manufacturer for further investigation.An analysis was performed on the picture that was provided by the customer.According to the picture, a preface guiding sheath with the cap separated from the hub was observed.The device was blood saturated and it was being used on the patient.No other outstanding details were observed.Per the picture review, the complaint reported by the customer as ¿brim cap detached¿ was confirmed according to the attached pictures where it is observed that the cap is separated from the hub.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.Even though the hub detachment condition was confirmed on the preface sheath, the root cause of this issue could not be conclusively determined during the analysis of the received picture.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster for evaluation and it was sent to the device manufacturer for further investigation.Visual analysis of the device revealed no damage or anomalies.The complaint reported by the customer as ¿brim cap detached¿ was confirmed according to the attached picture where it was observed that the cap was separated from the hub.However, the returned unit does not present any separation condition on the hemostasis valve.The device was thoroughly reviewed not observing any damages or anomalies.The exact cause of the reported event could not be conclusively determined during the analysis.Controls are in place to verify the product conditions; the manufacturing device are inspected 100% before leaving the facility.Neither the phr review nor the product analysis suggests that the reported event 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.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿brim cap detached¿ device returned analysis.-investigation findings: appropriate term/code not available (c22), fracture problem (c070603)/ investigation conclusions: cause not established (d15) / component code: circ cap (g04020) were selected as related to the picture that was provided by the customer on the ¿brim cap detached¿ issue.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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: 13503529
• Report Number: 2029046-2022-00259
• Device Sequence Number: 12100825
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: 10846835000030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2022

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: 06/03/2024
• Device Model Number: 301803MS
• Device Catalogue Number: 301803MS
• Device Lot Number: 18040580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2022
• Supplement Date Received by Manufacturer: 02/15/2022; 07/05/2022; 07/13/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/02/2022; 07/06/2022; 08/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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