MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR FOGARTY HYDRAJAW; CLAMP, VASCULAR

Model Number	HYDRA86
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
Event or Problem Description
It was reported that during use of the hydrajaw clamp there was a gap between the clamp and hydrajaw side of the insert since the hydrajaw was bent.This hydrajaw clamp insert easily got detached from the clamp.There was no allegation of patient injury.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.
Additional Manufacturer Narrative
Two hydrajaw inserts and one traction insert were returned for evaluation.The customer reports of gap between a clamp and bent hydrajaw were unable to be confirmed.Although hydrajaw insert appeared bent, the inserts were able to be attached to the lab cv5055(straight) and cv5050(angled) 86mm clamps and did not detach from the clamps.A 0.04" gap and a 0.03" gap was observed between the hydrajaw insert and the clamps.The observe gap on the insert was lower than 0.05" and was not out of specification.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Since the complaint affected unit was returned for evaluation and no defect was found a product non-conformance or device failure associated to manufacturing or design could not be confirmed.As part of the manufacturing process, all inserts go through an inspection process to make the units are straight and free of curvature.The device history record review was performed and no manufacturing non-conformances were identified associated to the reported malfunction.

• Brand Name: FOGARTY HYDRAJAW
• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22290018
• Report Number: 2015691-2025-05027
• Device Sequence Number: 12994346
• Product Code: DXC
• UDI-Device Identifier: 00690103044652
• UDI-Public: (01)00690103044652(17)270507(11)240507(10)65779717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: HYDRA86
• Device Lot Number: 65779717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown