MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC SPECTRE GUIDEWIRE; CATHETER

Model Number	7386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: upon rewiring newly deployed stent, wire got trapped behind stent wall and physician was unable to remove wire.Physician intentionally broke wire tip off and pinned remaining piece behind the stent.
Additional Manufacturer Narrative
One-unit was returned to vsi for evaluation.A returned product evaluation was completed.The distal section of the wire was separated.The damage at the separation point is consistent with exceeding tensile force.The separated piece of the wire was left in the patient.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.".

• Brand Name: SPECTRE GUIDEWIRE
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10669224
• Report Number: 2134812-2020-00066
• Device Sequence Number: 11504006
• Product Code: DQX
• UDI-Device Identifier: 20841156106505
• UDI-Public: (01)20841156106505
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 7386
• Device Lot Number: 675297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention