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	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an omniwire was used in a coronary procedure in a severely calcified lad.During use, resistance was encountered, and the distal tip broke off inside the patient.Attempts to remove the separated portion with a snare was unsuccessful; thus, a triple bypass surgery was performed for removal.This adverse event and product problem is being submitted due to tip separation, requiring additional intervention for removal.
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.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the omniwire was not returned for evaluation, thus no returned 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.
Additional Manufacturer Narrative
Block h3: the omniwire was returned for evaluation without the distal section.The distal section includes the distal coil, dome, and shaping ribbon.The returned proximal section includes the composite core, hypotube, distal core, sensor housing, pressure sensor, and core wire.At the location of separation, the core wire was exposed, resulting in the sharp edge observed.The measurement spec of the complete wire is 190 cm ± 5 cm and the returned section measured 190 cm.The missing section length of the omniwire was approx.3 cm.Block h6: the probable cause of the failure reported is likely due to handling during use.Manipulation and strain can damage internal and external components, resulting 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: 21779235
• Report Number: 3008363989-2025-00044
• Device Sequence Number: 15415097
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)250110(17)280110(10)0303376527
• 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): 05/16/2025

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: 0303376527
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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 CONSOLE.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown