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	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed the damage to the distal section of the turnpike and the separation of the tip.The guidewire was also returned and showed signs of damage consistent with torquing through a calcified lesion.The separated tip of the turnpike lp was on the guidewire.The most likely root cause for this failure is damage during use.
Event or Problem Description
Lad was wired antegrade on the support of a micro-catheter, physician ballooned and stented the vessel from mid to proximal, in order to performed post dilation.Physician needed to reinsert the micro-catheter to exchange the wire.The tip of the turnpike got dislodged, and stuck in the mid lad and substantial efforts were needed to remove it.Guideliner, additional wire, repeat ballooning.Final post dilation performed at the end with a short larger balloon.The distal graft anastomotic segment was left untouched.Good flow post procedure.Well tolerated overall.Left femoral access closed.Dilation of the lad.Lad had atherosclerosis, coronary artery calcification.No patient complications or injury reported.Current condition of patient is reported as "fine".

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7468974
• Report Number: 2134812-2018-00032
• Device Sequence Number: 1051392
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/29/2018

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: Physician
• Device Expiration Date: 11/14/2019
• Device Model Number: 5639
• Device Lot Number: 616038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR