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	Foreign Body In Patient (2687)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint 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.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 therapeutic coronary procedure.After measurement, the distal tip separated in the lad, and trapped with a stent.The procedure was completed using angio and fluoro.This adverse event and product problem is being submitted due to the tip separation requiring intervention, but retained in patient.
Event or Problem Description
It was reported that an omniwire was used in a therapeutic coronary procedure.After measurement, approx.60 mm of the distal tip separated in the patient.Approx.30 mm of the separated portion was entrapped with a stent in the lad, and the unstented portion extended into a small diagonal branch.The procedure was completed using angio and fluoro.This adverse event and product problem is being submitted due to the tip separation requiring intervention, but retained in patient.
Additional Manufacturer Narrative
Blocks a2, a3, a5 & a6: date of birth, age at time of event, sex, gender, ethnicity and race provided by the facility.Block b5: updated to include the measurement provided by the facility.Blocks b6 & b7: relevant tests/laboratory data, and other relevant history,including preexisting medical conditions provided by the facility.Block d10: concomitant medical products provided by the facility.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.
Additional Manufacturer Narrative
Blocks d9 & h3: the omniwire was returned for evaluation.Block h3: the omniwire was returned with only the proximal section.This includes the composite core, hypotube, distal core, sensor housing, pressure sensor, core wire, shaping ribbon, and a portion of the distal radiopaque tip; measuring approx.191 cm in length.Visual inspection found a stretched distal coil at the radiopaque tip.At the location of separation, the shaping ribbon and core wire were exposed, resulting in sharp edges.The distal section that was not returned includes a portion of the distal coil and dome; measuring approx.2.6 cm.The radiopaque tip specification is 3 cm ± 0.1 cm, which concludes that approx.0.4 cm was retained in the patient.The overall measurement spec is 190 cm ± 5 cm and the returned section measured 191 cm; however, it only appears to be within the measurement spec due to the stretching observed on the distal coil.Block h6: the probable cause of the tip separation 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: 22717649
• Report Number: 3008363989-2025-00099
• Device Sequence Number: 9628169
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)250320(17)280320(10)0303427157
• 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,Followup
• Report Date (Section B): 10/31/2025

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: 0303427157
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 10/25/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/14/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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: 6F, AVANTI INTRODUCER SHEATH.; GUIDE CATHETER, MFG AND SIZE UNK.; INTRODUCER SHEATH, MFG AND SIZE UNK.; MEDTRONIC: 6F, EBU 3.5 GUIDE CATHETER.; PHILIPS: INTRASIGHT CONSOLE.
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White