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

Model Number	89185J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an omniwire was used in a diagnostic coronary procedure in a moderately calcified mid lad.After advancing the wire a few centimeters through a non-philips guide catheter, an error message appeared.During pullback from the guide catheter, the wire separated approx.42 cm from the distal tip.The separated portion and the guide catheter were removed as a system.The procedure was postponed for a later date.No patient injury reported.This product problem is being submitted because the omniwire separated, was removed as a system, and resulted in delay of the procedure.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2, a3b, a5 & a6: dob, gender, ethnicity, and race are not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is germany.Block h3 & h6: the omniwire was not returned to the manufacturer 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 in two pieces without the non-philips guide catheter.The distal section (dome, distal coil, pressure sensor, solder joints, pressure sensor housing, and hypotube portion) measured approx.41.8 cm in length.The proximal section (hypotube portion, composite core, and conductive bands) measured approx.149.2 cm in length.Additionally, at the location of the separation, sharp edges were observed.The total length of the returned sections is 191 cm.The overall wire working length is 190 +/- 5 cm which concludes that all parts were accounted for, with no missing material detected.Block h6: the probable cause of the shaft separation is due to use/handling.Manipulation and strain can damage internal 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: 21714199
• Report Number: 3008363989-2025-00041
• Device Sequence Number: 21320230
• Product Code: DQX
• UDI-Device Identifier: 00845225003050
• UDI-Public: (01)00845225003050(11)240530(17)270530(10)0303206694
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/24/2025

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: 89185J
• Device Catalogue Number: 89185J
• Device Lot Number: 0303206694
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: MEDTRONIC: 6F GUIDE CATHETER; PHILIPS: CORE MOBILE CONSOLE; TERUMO: 6F INTRODUCER SHEATH
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 64 KG