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

Model Number	5639
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description states that the distal tip of the catheter separated and was retrieved on the wire.Additional information provided states that the device was torqued beyond the recommended revolutions without the catheter advancing.The turnpike ifu warns "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." the most likely root cause for this failure is clinician misuse.
Event or Problem Description
Complex case where the turnpike lp was used for peripheral disease in the right lower extremity.Access from the left groin was obtained.It was identified that the turnpike was torqued beyond the recommended revolutions without advancement of the catheter.The turnpike catheter tip separated from the catheter.The turnpike catheter tip separated from the catheter, however, the tip came out of the patient on the guidewire, and nothing was left in the patient, and no harm to the patient was noted.Procedure was aborted after turnpike issue.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7267845
• Report Number: 2134812-2018-00007
• Device Sequence Number: 19289487
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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: Physician
• Device Expiration Date: 07/06/2018
• Device Model Number: 5639
• Device Lot Number: 596463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/13/2018
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 69