MAUDE Adverse Event Report: AESCULAP INC. FOGARTY HYDRAGRIP CLAMP ANG JAW 235MM; VASCULAR FORCEPS (CLAMPS)

Model Number	MB095R
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event 1 it was reported to aesculap inc.That a fogarty hydragrip clamp ang jaw 235mm (part number: mb095r) was used during a hemi-arch replacement of ascending aorta with 32 mm dacron graft procedure on (b)(6) 2024.The following procedures were also reported: axillary artery cutdown for cannulation circulatory arrest with antegrade cerebral perfusion sternal repair with robiscek weave.According to the complainant the aortic cross clamp did not close completely to form a seal.Reportedly a second cross clamp was used and had the same results.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Event 1 investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Event 1.Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: FOGARTY HYDRAGRIP CLAMP ANG JAW 235MM
• Common Device Name: VASCULAR FORCEPS (CLAMPS)
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 20698841
• Report Number: 2916714-2024-00197
• Device Sequence Number: 17764526
• Product Code: DXC
• UDI-Device Identifier: 04046964566752
• UDI-Public: (01)04046964566752
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: MB095R
• Device Catalogue Number: MB095R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 49 KG
• Patient Race: Black Or African American