MAUDE Adverse Event Report: PHILIPS VOLCANO OMNIWIRE 89185J; WIRE, GUIDE, CATHETER

Model Number	89185J
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a diagnostic coronary procedure, the omniwire signal disappeared.A new wire was used to complete the procedure.No patient injury reported.During the returned product evaluation using a microscope, a small portion of the pressure sensor was broken but remained intact to the device.This product problem is being submitted in abundance of caution due to the fractured sensor.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Country is poland.It is likely the cracked sensor occurred during the procedure.Strain, impact, and forces associated with use can affect the integrity of the device.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 89185J
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 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 yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 16456538
• Report Number: 3008363989-2023-00011
• Device Sequence Number: 6560755
• Product Code: DQX
• UDI-Device Identifier: 00845225003050
• UDI-Public: (01)00845225003050(11)221111(17)251111(10)0302754230
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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 Expiration Date: 11/11/2025
• Device Model Number: 89185J
• Device Catalogue Number: 300000252891
• Device Lot Number: 0302754230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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: ALVISION: 6F JL 3.5 GUIDE CATHETER.; BALTON: 6F INTRODUCER SHEATH.
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White