MAUDE Adverse Event Report: TELEFLEX MEDICAL DEBAKEY AORTA CLAMP REV CVD AG; CLAMP, VASCULAR

Model Number	IPN005737
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It is being reported by a surgeon as not clamping properly.When used during an abdominal aortic aneurysm it did not completely occlude blood flow.Another clamp was used.No patient injury reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It is being reported by a surgeon as not clamping properly.When used during an abdominal aortic aneurysm it did not completely occlude blood flow.Another clamp was used.No patient injury reported.
Additional Manufacturer Narrative
(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 353610.(1) sample of 353610 lot i3 was received for evaluation.No visual concerns were noted.The jaws were inspected for defects with no concerns noted.The device was functionally tested through the full range of ratchet steps.The device performs as expected and the jaws are firmly locked in all positions.Tubing was used to simulate the aorta and visalize the cross section and observe the aperture during occlusion.(1) sample of 353610 lot i3 was received for evaluation.No visual concerns were noted.The jaws were inspected for defects with no concerns noted.A dimensional inspection was not required as part of this investigation.The device was functionally tested through the full range of ratchet steps.The device performs as expected and the jaws are firmly locked in all positions.Tubing was used to simulate the aorta and visalize the cross section and observe the aperture during occlusion.No confirmed complaints were received in this range with the same issue.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 353610.Unconfirmed and isolated.The sample will be retained for future review in the event that a trend develops.

• Brand Name: DEBAKEY AORTA CLAMP REV CVD AG
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12829471
• Report Number: 3011137372-2021-00320
• Device Sequence Number: 13809691
• Product Code: DXC
• UDI-Device Identifier: 24026704520279
• UDI-Public: 24026704520279
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K861924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: IPN005737
• Device Catalogue Number: 353610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown