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	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description stated that when the turnpike lp and the guidewire were pulled out of the patient body, the physician found that there is some extra material (like plastic) on the guidewire close to the tip of the turnpike lp.A returned product evaluation determined that the plastic like material was from the distal tip of the turnpike lp.The material was caught in the guidewire and separated from the catheter.The catheter showed signs of torque which caused the distal tip to become damaged.A manufacturing record review was completed and zero nonconformances were found.The most likely root cause is damage during use.
Event or Problem Description
During an angioplasty procedure, in order to cross a very calcified lesion, physician used a balloon with diameter of 1.0mm and a micro guide catheter.However both were unsuccessful.Hence, the physician used the turnpike lp 150cm, and rotated for ~5 mins in order to cross the lesion.However, the lesion still cannot be crossed.Finally physician decided not to use the turnpike lp and pull out the turnpike lp (together with guidewire).When the turnpike lp and the guidewire were pulled out of the patient body, the physician found that there is some extra material (like plastic) on the guidewire close to the tip of the turnpike lp.Physician suspected the extra materials on the guidewire came from the tip of the turnpike lp.No adverse event found with patient.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6673971
• Report Number: 2134812-2017-00059
• Device Sequence Number: 72163
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 06/08/2017

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: No Information
• Device Expiration Date: 04/18/2019
• Device Model Number: 5639
• Device Lot Number: 607217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/28/2017
• Patient Sequence Number: 1