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
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).
Additional Manufacturer Narrative
(b)(4).Additional information received on (b)(6) 2023 states that there was no patient harm or injury, their status is reported as "stable".The issue was resolved by using an alternative clip.3 clips were used on the patient.The reported complaint sample was received for evaluation and no concerns were noted upon visual inspection.A dimensional inspection was not required as part of the investigation.The device was functionally tested with no concerns noted.A review of complaints received in this range with the same issue identified no concerns with reference to this product.No problem was found with the device and the device functioned as expected.It was likely that the surgeon was applying this device to a vessel that was beyond the effective range of this clamp.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
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".

• 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: 17441731
• Report Number: 3011137372-2023-00201
• Device Sequence Number: 11440898
• 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: 10/24/2023
• 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