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

Model Number	7386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: the wire was caught in a stent.After multiple attempts to get it out, it broke off.Additional information received: 14may2021: looks like the wire was knuckled and when stent was deployed the tip was under stent.The rca was the vessel being fixed and the spectre wire was broke off in the vessel.A microcatheter was used to try and release wire and was unsuccessful, so then wire was pulled with the assist of microcatheter to break.The marked tip of wire was broken off.No snare was used because some of it was still stuck in prior stent deployed.Another stent was used to hold the rest of the wire down against vessel.
Additional Manufacturer Narrative
One-unit of spectre wire was returned for evaluation.No blood particulates were noted on the wire.The tip of the wire was damaged, unraveled and bent at the distal section.A manufacturing record review and no nonconformances was observed.The damages are likely to have occurred during use in procedure.Per ifu states the following warning and precaution.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 exercise care in handling the spectre guidewire during a procedure to reduce the possibility of accidental breakage, bending, or kinking additional information was received from the account.The procedure performed was pci for the rca vessel.The wire was knuckled when the stent was deployed.The tip of the wire was under the stent.Finecross was used to release the wire however this was unsuccessful.With the help/assistance of the fine cross, the wire was pulled to break it off.It is likely due to the manipulation of the wire against resistance with finecross could have caused the separation of the guidewire.The marked tip of the wire broke off.Another stent was used to hold rest of the wire down against the vessel.Snare was not employed due to the wire being stuck under the first deployed stent.

• Brand Name: SPECTRE GUIDE WIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11871866
• Report Number: 2134812-2021-00045
• Device Sequence Number: 16374616
• Product Code: DQX
• UDI-Device Identifier: 30841156101132
• UDI-Public: (01)30841156101132
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 06/18/2021
• Device Model Number: 7386
• Device Lot Number: 651506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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