MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC SPECTRE GUIDEWIRE

Model Number	IPN916605
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that: wire came out of patient and was stripped down to a thread.The wire was used on a highly calcified lesion additional information: during a pci with rotoblation.A spectre (endura)wire was used on a heavily calcified vessel.The wire was removed in its entirety after it unraveled.Another spectre wire was used without incident.There was no reported harm to the patient.
Additional Manufacturer Narrative
(b)(4).One-unit of spectre wire was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.Core wire was observed to be separated into proximal and distal portions.The wire was intact with the unravelled coil.The top-level assembly traveler (rt105826, lot 723121) was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly , and performance specifications.The supplier was notified of the complaint.Case details were reviewed.Customer stated "wire came out of the patient (male 71y) and stripped down to a thread." one unit of spectre was returned to vsi/teleflex for evaluation.Coil of the wire was unravelled from the core wire.The core wire was separated but intact as one unit.Damages are likely to have occurred during use in the procedure when operated against resistance.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, or kinking.Additional information was requested.A response was received.Lesion was highly calcified.Pci with rotablation was performed.A video was provided.The video lasted only 1s.Two guidewires were noted.No other information was provided nor did the video indicate the issue of breakage of the wire.Other devices such as a guide catheter and a catheter with two marks likely representing a balloon catheter was noted.It is likely due to anatomical factors and/or concomitant device interaction could have led to the separation of the core wire and unravelling of the coil.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported that: wire came out of patient and was stripped down to a thread.The wire was used on a highly calcified lesion.Additional information: during a pci with rotoblation.A spectre (endura)wire was used on a heavily calcified vessel.The wire was removed in its entirety after it unraveled.Another spectre wire was used without incident.There was no reported harm to the patient.

• Brand Name: SPECTRE GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17123568
• Report Number: 2134812-2023-00027
• Device Sequence Number: 20679647
• Product Code: DQX
• UDI-Device Identifier: 10841156108014
• UDI-Public: 10841156108014
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: Health Professional
• Device Expiration Date: 02/21/2025
• Device Model Number: IPN916605
• Device Catalogue Number: 7386
• Device Lot Number: 723121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 71 YR
• Patient Sex: Male