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

Model Number	89185
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the omniwire was not returned, thus no product investigation was performed.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 coronary procedure.During use, a non-philips balloon was advanced over the wire.The balloon was inflated/deflated but when it was being removed, it got stuck on the wire; therefore, was removed as a unit.A new wire was used to complete the procedure.No patient injury reported.This product problem is being submitted because the omniwire and balloon were removed as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Block d4 & h4: correction received on (b)(6) 2026: lot number (from "0303554897" to "0303597078"), serial number (from (b)(6) to (b)(6), expiration date (from "21-dec-2028" to "03-oct-2028", unique identifier (from (b)(4) to (b)(4), and device manufacture date (from "21-aug-2025" to "03-oct-2025").Blocks d9 & h3: the omniwire was returned on (b)(6) 2026 and evaluated on (b)(6) 2026.Block h3: the omniwire was returned intact to a non-philips balloon and could not be removed.Visual inspection found no unusual characteristics of the omniwire.Block h6: the probable cause of the reported failure is damage during handling/use as evidenced by the balloon stuck on the wire.Manipulation and strain can damage internal and external components and result in the reported failure.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.

• 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: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 23928986
• Report Number: 3008363989-2025-00170
• Device Sequence Number: 8824927
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)251003(17)281003(10)0303597078
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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 Model Number: 89185
• Device Catalogue Number: 89185
• Device Lot Number: 0303597078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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: CORDIS: 7F AVANTI INTRODUCER SHEATH.; CORDIS: 7F XB4 GUIDE CATHETER.; PHILIPS: INTRASIGHT SYSTEM.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White