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

Model Number	HYDRA61
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, before use in patient, a small hole was noticed in the primary packaging of this fogarty hydrajaw clamp insert set.There was no allegation of patient injury.The device was available for evaluation.Patient demographics not available, since the product was not used on any patient.
Additional Manufacturer Narrative
Initially 9 units from the same lot number were reported with the same issue and the medwatch was submitted under reference 47828 as received, 5 of these units were confirmed to have the reported failure.Therefore, each device is being reported separately under medwatch references: 47828, 48273, 48274, 48275, 48276 (ew ref 2024-10281-01, 2024-10281-02, 2024-10281-03, 2024-10281-04 and 2024-10281-05 respectively) the device was received for evaluation, however the investigation is still on-going.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.
Additional Manufacturer Narrative
The product was received evaluation.The report of small hole in packing was confirmed.Package was received sealed.Tyvek cover was noticed punctured.Lab findings were aligned to the customer photo.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 further investigation at the manufacturing site, a cause for this failure was not able to identify and the defect could not be replicated.With the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore, no root cause could be established.There is total of five (5) complaints reported and confirmed with the reported issue of perforated tyvek, these complaints are from the same hospital.Initially customer reported 9 units from the same lot number presenting the same reported failure (reported under report id: 2015691-2024-03678), however based on the evaluation of the returned units, 5 units were confirmed to be defective.For the other 4 no defect could be observed.The 5 units presenting the reported issue were finally reported individually, one medwatch for each device, under report ids 2015691-2024-03678, 2015691 2024 03871, 2015691-2024-03872, 2015691-2024-03873, 2015691-2024-03874 (registered as manufacturer ref 2024-10281-01, 2024-10281-02, 2024-10281-03, 2024-10281-04 and 2024-10281-05, respectively).The 4 units where no defect was found are no longer considered as reportable incidents.

• 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 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: 19390348
• Report Number: 2015691-2024-03872
• Device Sequence Number: 7799371
• Product Code: DXC
• UDI-Device Identifier: 00690103044645
• UDI-Public: (01)00690103044645(17)261116(11)231117(10)65398600
• 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): 08/06/2024

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: HYDRA61
• Device Lot Number: 65398600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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