MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY-HYDRAGRIP SURGICAL CLAMPS; CLAMP, VASCULAR

Model Number	EVERGRIP86
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product 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 clamping of the patient aorta, this pair of evergrip inserts did not hold and fell off.This caused the clamps spike to perforate the aortic wall, leading to patient minimal blood loss.This aortic perforation was fixed with a surgical suture of about 0.5x0.5 cm.The inserts could be retrieved with no need of additional intervention.No further patient consequences were reported.The inserts were available for evaluation.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section d9, h6 (component code), h6 (impact code), h6 (investigation findings) and h6 (investigations conclusions).Finally, no device was available for evaluation as it was not retained by the customer.Without return of the product, a complete investigation of the reported event is unable to be performed.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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.Further investigation was performed at the manufacturing site.As part of the device manufacturing, before the molding process, the ribs component of the insert are inspected to ensure it is straight and that the pins are inserted into the holes and aligned.After molding process the units are inspected to verify the ribs of the inserts are not folded.In a sampling process units are visually inspected to ensure they are free from curvatures and appear straight and a second inspection is performed using a hemostat to verify the inserts fit along the entire hemostat, fit securely without shifting or falling off, ensuring a stable and consistent fit.

• Brand Name: FOGARTY-HYDRAGRIP SURGICAL CLAMPS
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22493138
• Report Number: 2015691-2025-05666
• Device Sequence Number: 4272615
• Product Code: DXC
• UDI-Device Identifier: 00690103044577
• UDI-Public: (01)00690103044577(17)270502(11)240502(10)65694915
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVERGRIP86
• Device Lot Number: 65694915
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 106 KG