MAUDE Adverse Event Report: TELEFLEX MEDICAL DIETHRICH BULLDOG ANG 12MM; CLAMP, VASCULAR

Catalog Number	353154
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during coronary bypass surgery, the clamp is not occluding the vessel as blood is still "getting through".No report of patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The reported complaint could not be confirmed based upon evaluation of the returned sample.A sample was received for evaluation.No visual concerns were noted.A dimensional inspection was not required as part of this investigation.The device was functionally tested with no concerns noted.3 additional complaints were received from the same customer for the same device; however, no confirmed complaints were received in this range with the same issue.A trend review was performed for notifications pertaining to incoming inspection, stock checks, and product returns and no concerns were noted.The device functioned as expected and it was likely that the surgeon was applying this device to a vessel that was beyond the effective range of this clamp.No further actions were required.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that during coronary bypass surgery, the clamp is not occluding the vessel as blood is still "getting through".No report of patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: DIETHRICH BULLDOG ANG 12MM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17447108
• Report Number: 3011137372-2023-00202
• Device Sequence Number: 7416340
• Product Code: DXC
• UDI-Device Identifier: 24026704519617
• UDI-Public: 24026704519617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K861924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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 Catalogue Number: 353154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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