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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn # (b)(4).Complete udi is not availabale as the lot# was not provided by the customer.
Event or Problem Description
It was reported that: "i am reaching out regarding a damaged teleflex product (ref 5638).This product was used during a patient procedure and it malfunctioned." additional information received on 19aug2024: "i spoke with the manager she was in the case.She told me she does not have the "resources" to retrieve all the details, but told me that it was a very difficult case with a tight lesion and the turnpike seemed to be stuck and when they tried to maneuver the catheter a piece of the tip seemed to dislocate.They placed a wire next to the microcatheter and were able to remove everything together.Nothing was left behind and they were able to complete the case using another turnpike lp.The patient was reported as fine.".
Additional Manufacturer Narrative
Qn#(b)(4).One unit of turnpike was returned for evaluation.Blood particulates were noted on the unit.The unit was decontaminated and inspected.Approximately 2 mm of tip separation was observed.The remaining tip material was fatigued.Lumen of the shaft was also bulged.Separated tip was not returned.A dhr review was completed for lot 73m2200338.No issues or non-conformities were noted.The damages are likely to have occurred during use when advanced against a tight lesion.The ifu states the following warning and precaution: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by f luoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Do not rotate the catheter more than two (2) consecutive 360 rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.No information was provided on number of rotations performed with the tip trapped in the lesion.As per the additional information received, the tip was removed.Another turnpike was used to complete the case.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported that: "i am reaching out regarding a damaged teleflex product (ref (b)(4)).This product was used during a patient procedure and it malfunctioned." additional information received on 19aug2024: "i spoke with the manager she was in the case.She told me she does not have the "resources" to retrieve all the details but told me that it was a very difficult case with a tight lesion and the turnpike seemed to be stuck and when they tried to maneuver the catheter a piece of the tip seemed to dislocate.They placed a wire next to the microcatheter and were able to remove everything together.Nothing was left behind and they were able to complete the case using another turnpike lp.The patient was reported as fine.".

• 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: 20105582
• Report Number: 2134812-2024-00047
• Device Sequence Number: 8340719
• Product Code: DQY
• UDI-Device Identifier: 10841156108731
• UDI-Public: (01)10841156108731(11)230207(17)241213(10)73M2200338(21)
• Combination Product (Y/N): N
• 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): 08/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5638
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown