MAUDE Adverse Event Report: TELEFLEX MEDICAL LARGE WECK CLIP APPLIER; CLIP, IMPLANTABLE

Device Problems Activation, Positioning or Separation Problem (2906); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 09/17/2020

Event Type  Injury  

Event Description

Patient underwent a coronary artery bypass graft x3, had unplanned return to the or for postop bleeding.Findings at surgery "copious clot around left lung.There was active bleeding from the distal stump from the left internal mammary artery.Both large hemoclips had failed most likely due to faulty clip applier".There was a malfunction of the deployment of the hemoclips.

• Brand Name: LARGE WECK CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 10785028
• MDR Text Key: 214596272
• Report Number: 10785028
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16425 DA