MAUDE Adverse Event Report: TELEFLEX INCORPORATED PILLING; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	IPN915270
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Aortic punch device gets stuck.

• Brand Name: PILLING
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 18806476
• Report Number: 18806476
• Device Sequence Number: 7342168
• Product Code: DWS
• UDI-Device Identifier: 14026704697943
• UDI-Public: (01)14026704697943
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/14/2024
• Report Date (Section F): 02/15/2024

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: IPN915270
• Device Catalogue Number: DP-40K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White
• Date Report Sent to FDA: 02/15/2024