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

Model Number	7386
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned to vsi/teleflex for investigation.Additional information was requested and no response was received.Based on the limited information and no product evaluation, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported during a pci of the rca that the tip of the spectre wire broke off in vessel.Physician was unable to snare it out for removal.Remaining portion stented against wall and left in vessel.Product was discarded so there is nothing to return.No further complications were reported.

• Brand Name: SPECTRE GUIDEWIRE
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneaplois, mn
• MDR Report Key: 10362718
• Report Number: 2134812-2020-00043
• Device Sequence Number: 16386753
• Product Code: DQX
• UDI-Device Identifier: 30841156101132
• UDI-Public: (01)30841156101132
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: 7386
• Device Lot Number: 665287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/04/2020
• 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