MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS

Model Number HYDRA86

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.A device history record review was completed and documented that device met all specifications upon distribution.No further actions will be taken at this time.The hydragrip insert is a radiopaque clamp insert used for temporary local vascular control.If vascular control is lost, bleeding may occur and therefore delay the procedure.Per the ifu, care should be taken to ensure a firm grasp of the vessel when two compliant inserts are used, since traction is reduced and the possibility of slippage is increased.It is standard clinical practice to inspect all clamps and inserts prior to usage.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 Description

It was reported that the fogarty hydragrip inserts got detached from the v.Mueller cosgrove flex clamp and fell into the patient body.The incident occurred approximately 10 minutes after abdominal aortic aneurysmectomy (artificial blood vessel replacement) was initiated causing bleeding from abdominal aorta (central side to renal artery).The reporter noted that the inserts got detached from the clamp when clamping the abdominal aorta.The abdominal aorta was clamped by another clamp and the surgery was continued.The inserts were removed from the patient without difficulty.The surgery took a few minutes longer than expected due to the event.Additionally, it was confirmed that the patient had been receiving blood transfusions due to the original surgery from the beginning and it was not reported that additional transfusions or autotransfusions were required as a result of the event.The clamp was not new and had been previously used.The clamp was purchased in 2001 and the customer suspected the clamp malfunction rather than the inserts malfunction.The inserts were discarded at the hospital.The patient was an (b)(6) year old male.There were no patient complications reported.

Manufacturer Narrative

This follow-up report is a correction to the previous report in which the selection for adverse event in b1 was not populated.

• Brand Name: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• Type of Device: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11709265
• MDR Text Key: 252258532
• Report Number: 2015691-2021-02603
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: HYDRA86
• Device Catalogue Number: HYDRA86
• Device Lot Number: 63364504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR