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

Model Number	5638
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A returned product evaluation confirmed that the distal tip section of the catheter was severely damaged and a piece was missing.The missing piece was reported to be left inside the patient's vasculature.The damage found on the returned unit is consistent with torquing the catheter against resistance while the tip is fixed.The most likely root cause is damage during use.Manufacturing record review was completed no non-conformances to this event was noted.
Event or Problem Description
Physician was using the turnpike lp for a cto.He felt the tip became lodged in an area of calcium and the tip dislodged.The tip was not able to be retrieved.Additional information received via medsun uf importer report# (b)(4): the patient has very calcified arteries and the catheter tip tore in the calcium.The tip embolized down and could not be retrieved due to distal location.The coronary artery had normal flow at the end of the case.Other information received about the patient: that may have influenced the outcome of the event: on (b)(6) 2016 lhc to fix left circumflex but failed with embolization of balloon tip to distal lcx.On (b)(6) 2017 patient went for staged pci of the left cx laser atherectomy and during the procedure had fracture of the angioplasty balloon which embolized distal left cx and was unable to retrieve after multiple attempts.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7072011
• Report Number: 2134812-2017-00103
• Device Sequence Number: 10978944
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/03/2017

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: 12/02/2018
• Device Model Number: 5638
• Device Lot Number: 600512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR