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	Death (1802)
Date of Event	11/30/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
It is likely that the tortuous environment contributed to the device failure.The turnpike is designed to be used in extreme tortuosity.The evidence found during the returned product evaluation show that the catheter was twisted and shaft was damaged due to torquing against resistance.The event description along with the returned product evaluation provided sufficient evidence to determine that the most likely root cause was misuse by clinician.The event description states, "applying significant torque to the device".The ifu specifically warns to "never advance, withdraw or rotate an intravascular device against resistance until the cause of resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury." in addition, the ifu cautions, "when the catheter is in the body, it should be manipulated only under fluoroscopy.Do not attempt to move the catheter without observing the resultant tip response, as catheter damage or vessel injury may occur.".
Event or Problem Description
Cto of left vena, stuck in septum, tip of catheter broke: during the treatment of an rca cto using a retrograde approach, physician had to remove a (first) turnpike lp catheter due to the loss of guidewire movement after applying significant torque to the device.He subsequently went back in with a second turnpike lp and also lost wire movement.He removed one guidewire and tried to re-advance a second wire.He was unable to advance the second wire.During a subsequent attempt to withdrawal of the turnpike significant resistance was encountered.After applying clockwise and counterclockwise rotations the catheter shaft detached leaving a portion of the turnpike catheter in the septal and a portion into the left anterior descending artery.The physician felt that he had over rotated the catheter beyond the device's limits.The patient was sent to surgery, the catheter was removed and the patient received coronary artery bypass instead of the planned cto-pci.The patient is reported to be doing fine.Received (b)(6) 2016: new information regarding this case.We have become aware that the pt.Suddenly deteriorated and became hypotensive.The surgeon had to open her up in the ccu, but she did not survive.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6195513
• Report Number: 2134812-2016-00088
• Device Sequence Number: 876077
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: +M20656390/$$3180915598415D
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: 09/15/2018
• Device Model Number: 5639
• Device Lot Number: 598415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/21/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention