MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC RADIAL INTRODUCERSHEATH STANDARD KIT; GUIDEWIRE

Model Number	9001
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description states that the guidewire fractured at the weld point.A manufacturing record review was completed and zero nonconformances were found.This guidewire is a supplied component for the vsi kit.The supplier investigation determined that the guidewire tip prolapsed on itself while being rotated and torqued.The guidewire was not separated at the weld joint.The separation was roughly 2 cm from the distal tip and the outer coil was stretched.This is consistent with the wire being forcefully pulled after becoming stuck.
Event or Problem Description
Physician informed that the guidewire fractured at the transition and or weld location.This is where the floppy wire component connects with the solid back end of the wire.Physician claims that he felt some resistance when inserting our wire in the needle hub.No patient impact reported.

• Brand Name: RADIAL INTRODUCERSHEATH STANDARD KIT
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6816777
• Report Number: 2134812-2017-00066
• Device Sequence Number: 1589309
• Product Code: DQX
• UDI-Device Identifier: M20690011
• UDI-Public: M20690011
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043398
• 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): 07/27/2017

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: 04/30/2018
• Device Model Number: 9001
• Device Lot Number: 595079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1