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

Model Number	89185J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coronary procedure in the proximal lad, the omniwire fractured in the patient.A snare was used, but after hours of trying to remove unsuccessfully, the patient was transferred to a different facility for surgical removal consideration.The portion of the omniwire (33 cm) was removed during by-pass.The patient's condition is unknown.This adverse event and product problem is being submitted due to the wire separation requiring surgical intervention for removal.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Relevant test: no information available.Suspect products: not applicable for this device.Implant date: not applicable for this device.The device has not been returned by the facility, thus no returned product investigation was performed.Recall: 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 d4 correction: updated serial number from (b)(6).To (b)(6)., lot number from 0302535769 to 0302535764, udi number from (b)(4) to (b)(4)., expiration date from 3/10/2025 to 3/9/2025.Block h3: the omniwire was returned without a portion of the shaping ribbon, distal coil, and dome.The shaping ribbon and the distal coil were broken and exposed with sharp edges.The returned shaping ribbon measured at 2 cm, which indicates 1.05 cm was not returned.The returned distal coil measured at 1 cm, indicating that 33 cm was not returned.This aligns with the 33 cm that was removed from the patient.Block h4 correction: device manufacture date from 3/10/2022 to 3/9/2022.Block h6: the probable cause for the separation is unexpected damage in use.Improper handling during the use of the device such as 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: paulette nicole montes ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14762726
• Report Number: 3008363989-2022-00049
• Device Sequence Number: 6106804
• Product Code: DQX
• UDI-Device Identifier: 00845225003050
• UDI-Public: (01)00845225003050(11)220309(17)250309(10)0302535764
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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 Expiration Date: 03/09/2025
• Device Model Number: 89185J
• Device Catalogue Number: 300000252891
• Device Lot Number: 0302535764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White