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

Model Number	89185
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this device.Block d1: per the product code dqx, this is not indicated or approved as a life-sustain/support device.Blocks d6 & d7: not applicable for this device.Block h3: the omniwire was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing, the device failed the signal/zero test due to an error message displayed by the console.Block h6: the probable cause of the reported failure is an electrical conductivity issue between the connector and the conductive bands which resulted in instabilities of signal.Manipulation and strain on the wire can cause damage to internal components and can result in the reported failure.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 an emergent coronary diagnostic procedure.During use, the catheter failed to normalize, even after multiple attempts.The procedure was completed with a new device, no patient injury reported.This product problem is being reported because the wire could not be used during an emergent case; resulting in a potential for harm due to the delay of the procedure.

• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 21953468
• Report Number: 3008363989-2025-00059
• Device Sequence Number: 15733676
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)241128(17)271128(10)0303352214
• 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): 05/02/2025

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: 0303352214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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: PHILIPS VOLCANO: INTRASIGHT MOBILE SYSTEM; UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown