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	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an omniwire was used in a diagnostic coronary procedure.Prior to use, the omniwire was flushed, then shaped with the introducer tool, as usual.During use, resistance was noted near the subclavian, and the omniwire buckled and would not advance further.The omniwire was withdrawn from the non-philips watchdog hemostasis valve, when a yellow plastic string like material appeared to have been stripped off.Upon removal of the guide catheter from the patient, no kinks, thrombus, or residual material was observed.The procedure was completed with a j wire with no patient injury reported.During the device evaluation, missing material from the core wire was observed.This product problem is being submitted due to missing material.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b5 & g3: although the reported event stated that material appeared to have been stripped off, this was not confirmed until the device evaluation performed on 09oct2025.Blocks b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the omniwire was returned for evaluation.Visual inspection found a bent and stretched distal coil.Additionally, the composite core was bent, and a portion of the composite core was peeled with missing material observed.During the guide wire bend test, no resistance was noted when rotating, advancing, or retracting the omniwire.Block h6: the probable cause of the missing material is likely due to rough handling or manipulation of the device during use.Manipulation and strain can damage internal components and result in the reported failure.The probable cause of the guidewire movement issue could not be determined since it passed the bend test.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.

• 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: 23492564
• Report Number: 3008363989-2025-00137
• Device Sequence Number: 13010102
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)250612(17)280612(10)0303495479
• 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
• Report Date (Section B): 11/06/2025

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: 0303495479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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: PHILIPS: INTRASIGHT SYSTEM.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown