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

Model Number	5638
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One turnpike lp was returned to vsi for evaluation.A manufacturing record review was completed and zero related nonconformances were found therefore supporting the device met material, assembly and performance specifications.A returned product evaluation was also completed.A kink was present in the shaft of the turnpike; it cannot be concluded how and when this kink occurred.The reported tip "fracture" was confirmed to be a tip separation; approximately 0.5-1.0mm of material was missing from the distal tip.The ptfe liner was exposed at the distal tip, which indicates the ptfe liner was present and had been manufactured correctly.There were marks on the distal portion of the catheter, which is consistent with rotating the catheter against calcification.In addition, torque damage was present, supporting the conclusion that the tip separation was most likely caused by torqueing the catheter with the tip fixed.
Event or Problem Description
Physician was utilizing a turnpike lp in a heavily calcified rca.As he was spinning the turnpike lp, he felt it catch and it would no longer spin.He spun it the opposite direction to free it and upon removal noticed a "fracture" in the tip.Attempts were made to obtain additional information on how the tip was retrieved however, no reply has been received.No patient injury was reported.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8401193
• Report Number: 2134812-2019-00013
• Device Sequence Number: 1827900
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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 Expiration Date: 08/22/2020
• Device Model Number: 5638
• Device Lot Number: 631479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other