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	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing record review was completed and zero nonconformances were found.There was no returned product to complete an evaluation on.Therefore, the root cause is undeterminable.
Event or Problem Description
Md noticed that the tip of device separated from shaft, the tip dislodged, however, was intact on the wire.Md removed the entire system without incident or harm to the patient.Procedure resumed without event.No harm to patient.All of the device retrieved.Additional information received, the device will not return for investigation.Received information on (b)(6) 2017, on medsun mandatory and voluntary report form uf/importer # (b)(4).

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7176065
• Report Number: 2134812-2018-00004
• Device Sequence Number: 16505839
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: Physician
• Device Expiration Date: 09/07/2019
• Device Model Number: 5638
• Device Lot Number: 612461
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/09/2018
• Patient Sequence Number: 1
• Patient Age: 73 YR