MAUDE Adverse Event Report: TELEXFLEX LLC. TURNPIKE LP CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	5639
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Tuenpike lp catheter lot # 73b24001018, ref 5639, exp 2026-02-27.Came apart while in use and adhered to guide wire.Both pieces were retrieved by performing physician.No impact to patient or others.

• Brand Name: TURNPIKE LP CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEXFLEX LLC.; minneapolis MN
• MDR Report Key: 19839562
• Report Number: MW5157635
• Device Sequence Number: 6888457
• Product Code: DQY
• UDI-Device Identifier: 10841156110697
• UDI-Public: (01)10841156110697
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2026
• Device Catalogue Number: 5639
• Device Lot Number: 73B2401018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White