MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. SPECTRE GUIDEWIRE; CATHETER GUIDEWIRE

Model Number	7386
Medical Device Problem Codes	Detachment Of Device Component (1104); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed the damage to the spectre wire.The core wire was broken and about 1.5 cm were missing.The coil was unraveled and broken.The spectre ifu warns; "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel injury.".
Event or Problem Description
During routine pci of coronary artery dr k used spectre wire as a buddy wire to deliver stent.Dr.Trapped/jailed spectre wire with stent and spectre wire knuckled, and got stuck on distal struts of stent and was broken when he attempted to remove spectre gw.Tip of spectre was left behind in vessel, and a second stent was deployed to cover wire.No patient impact was reported.

• Brand Name: SPECTRE GUIDEWIRE
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7439311
• Report Number: 2134812-2018-00026
• Device Sequence Number: 16528987
• Product Code: DQX
• UDI-Device Identifier: M20673861
• UDI-Public: M20673861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: No Information
• Device Expiration Date: 01/20/2020
• Device Model Number: 7386
• Device Lot Number: 619194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 59