MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE LP 135CM; CATHETER, PERCUTANEOUS

Catalog Number	5638
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "tip of tp lp broke off in calcified lad." additional information received on 14apr2025: "the turnpike lp with a wire stuck in the catheter minus the tip was discarded.The lad was severely calcified with a mid cto.The lps tip was trapped in the lad cto.I didn't see how many times the doctor torqued the catheter per ifu.The tip remained in the cto.The rest of the turnpike lp and wire were removed out of the body.Only a few millimeters of the tip were broken off in the cto.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Correction to section d: udi number - the udi number was corrected to (b)(4).Additional information: no return product evaluation could be completed as the device was not returned for investigation.A dhr review was completed lot 73m2400308 and no issues or nonconformities were noted.Case details were reviewed.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "tip of tp lp broke off in calcified lad.".Additional information received on 14apr2025: "the turnpike lp with a wire stuck in the catheter minus the tip was discarded.The lad was severely calcified with a mid cto.The lps tip was trapped in the lad cto.I didn't see how many times the doctor torqued the catheter per ifu.The tip remained in the cto.The rest of the turnpike lp and wire were removed out of the body.Only a few millimeters of the tip were broken off in the cto.".

• Brand Name: TURNPIKE LP 135CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21932819
• Report Number: 2134812-2025-00015
• Device Sequence Number: 12924347
• Product Code: DQY
• UDI-Device Identifier: 10841156110680
• UDI-Public: (01)10841156110680(11)250212(17)261213(10)73M2400308(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 5638
• Device Lot Number: 73M2400308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 66 YR
• Patient Sex: Female