MAUDE Adverse Event Report: PUERTO RICO FOGARTY-HYDRAGRIP SURGICAL CLAMPS; CLAMP, VASCULAR

Model Number	EVERGRIP86
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was further informed that the device was not available for evaluation since it was discarded at hospital.However, imagery was provided for evaluation.An engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
As reported, during use in patient, this evergrip86 insert did not hold and fell off inside the patient, the insert was removed and replaced.As per customer opinion, this can be dangerous if it occurs directly while clamping the aorta as this can cause severe damage to the aorta and may require replacement.There was no allegation of patient injury.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Without return of the product, a complete investigation of the reported event is unable to be performed.Nevertheless, four images provided were reviewed.The report of "insert does not hold" was confirmed.Images showed inserts attached to a clamp.A small gap was visible between inserts and clamp at both proximal and distal sides.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The controls to defect the failure mode being evaluated are established in the manufacturing process.As part of the device manufacturing, the molding process includes inspections to ensure that the ribs component of the insert are straight.Further inspection procedures are in place to verify that the units are free from curvature and appear straight and to ensure that the inserts fit securely.

• Brand Name: FOGARTY-HYDRAGRIP SURGICAL CLAMPS
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): PUERTO RICO; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22393467
• Report Number: 2015691-2025-05415
• Device Sequence Number: 9126938
• Product Code: DXC
• UDI-Device Identifier: 00690103044577
• UDI-Public: (01)00690103044577(17)271014(11)241014(10)66006132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: EVERGRIP86
• Device Lot Number: 66006132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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
• Patient Sex: Unknown