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	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Locks e1 & g2: country is (b)(6).Block h3 & h6: the omniwire was not returned for evaluation, 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, the distal portion of the device separated within the non-philips introducer sheath; therefore, both were removed together with no additional intervention.No patient injury reported.This product problem is being submitted because the omniwire distal portion separated.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h2: based on the device analysis, the component code was updated to g04129- tip (from g04112- rod/shaft).Block h3: the omniwire was returned without the distal section.The returned section includes the composite core, hypotube, distal core, sensor housing, pressure sensor, core wire, and a portion of the shaping ribbon, measuring approx.190 cm in length (spec is 190 cm ± 5 cm).At the location of the separation, the core wire and shaping ribbon were exposed with sharp edges observed.The distal section that was not returned includes the distal coil, dome, radiopaque tip, and remaining portion of the shaping ribbon, measuring approx.0.05 cm (spec is 3.05 cm); therefore, approx.3 cm of the distal tip was not returned.Block h6: the probable cause of the reported failure is likely due to handling during use.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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 23762382
• Report Number: 3008363989-2025-00154
• Device Sequence Number: 9933743
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)250623(17)280623(10)0303492788
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 0303492788
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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: GUIDE CATHETER, MFG AND SIZE UNK; INTRODUCER SHEATH, MFG AND SIZE UNK; PHILIPS: INTRASIGHT CONSOLE
• Patient Sex: Unknown