MAUDE Adverse Event Report: VOLCANO CORPORATION OMNIWIRE PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	89185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2, a3b & a4: not available from facility.Block b6: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the omniwire was discarded, thus no returned product investigation was performed.Block h6: per the ifu precautions: in order to minimize patient risk, exercise caution when using the pressure guide wire in a stented vessel.When advancing or withdrawing the pressure guide wire in a stented vessel, in the event that the stent is not fully apposed against the vessel wall, the pressure guide wire may become entangled in one or more stent struts.This may result in entrapment of the pressure guide wire, damage to the pressure guide wire and/or stent dislocation.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that an omniwire was used in a therapeutic coronary procedure in a severely calcified rca.During use, resistance was encountered in the ostium of the rca and the guidewire got caught in a stent, resulting in tip separation.The separated portion was removed with a snare.The procedure was completed successfully with a non-philips wire.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).

• Brand Name: OMNIWIRE PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 21438883
• Report Number: 3008363989-2025-00023
• Device Sequence Number: 4528393
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)241127(17)271127(10)0303349855
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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 Model Number: 89185
• Device Catalogue Number: 89185
• Device Lot Number: 0303349855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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: 6F INTRODUCER SHEATH, MFG UNK.; GUIDE CATHETER, MFG AND SIZE UNK.; PHILIPS: INTRASIGHT CONSOLE.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White