MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® FIBRA® CLAMP INSERT; CLAMP, VASCULAR

Model Number	A0G01
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	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: [cardiac surgery].Event description: [hospital: [hospital name], distributor: [distributor name], model#: a0g01, lot#: 1510129.The procedure was cardiac surgery.While using the inserts to block blood flow, the rubber part of the inserts detached from the product.The surgeon did not notice anything wrong during the setup or when it started to be used.However, the detachment was discovered later during its use.The procedure was completed successfully by using the insert continuously.The product in question was returned from the hospital.Please investigate the possible root cause.The hospital has requested the investigation report.Additional information obtained via email on 27jan2025: no other devices or instruments were used.The surgical team noticed during aortic clamping that the device malfunctioned.The insert pad partially detached from the insert.The pad did not fall into the patient's body.There was no damage to the vessel.The surgeon noticed something unusual while using the insert, which led to the identification of a malfunction.Type of intervention: [the procedure was completed successfully by using the insert continuously].Patient status: [no health damage was reported for the patient].
Event or Problem Description
Procedure performed: [cardiac surgery] event description: [hospital: [hospital name] distributor: [distributor name] model #: a0g01.Lot #: 1510129.The procedure was cardiac surgery.While using the inserts to block blood flow, the rubber part of the inserts detached from the product.The surgeon did not notice anything wrong during the setup or when it started to be used.However, the detachment was discovered later during its use.The procedure was completed successfully by using the insert continuously.The product in question was returned from the hospital.Please investigate the possible root cause.The hospital has requested the investigation report.Additional information obtained from applied medical rep via email on 27jan2025: no other devices or instruments were used.The surgical team noticed during aortic clamping that the device malfunctioned.The insert pad partially detached from the insert.The pad did not fall into the patient's body.There was no damage to the vessel.The surgeon noticed something unusual while using the insert, which led to the identification of a malfunction.Type of intervention: [the procedure was completed successfully by using the insert continuously.] patient status: [no health damage was reported for the patient.].
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.Visual inspection confirmed the partial pad separation on the insert.Based on the condition of the returned unit, it is likely that the reported event occurred during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.Corrections were performed to section g2.

• Brand Name: STEALTH® FIBRA® CLAMP INSERT
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21324176
• Report Number: 2027111-2025-00345
• Device Sequence Number: 20812817
• Product Code: DXC
• UDI-Device Identifier: 00607915114725
• UDI-Public: (01)00607915114725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Model Number: A0G01
• Device Catalogue Number: 101371301
• Device Lot Number: 1510129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown