MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA 10185P; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Date of birth not available.Not applicable for this device.Not applicable for this device.The verrata 10185p was discarded and not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Based on the complaint details, the verrata wire got caught on the calcium and was unable to be removed; resulting in the wire separation.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 a verrata 10185p wire was used in a diagnostic coronary procedure in the lad artery.During use, the wire was unable to cross the lesion.While attempting to remove from the patient, the distal end got lodged into the calcium, the wire uncoiled and separated in two pieces.The proximal portion of the wire was removed, leaving the distal portion in the patient.Several snare devices with different sizes were used to retrieve, but unable to be removed; therefore, it was pushed up against the vessel wall with a stent.Patient was transferred to ccu for continued cardiac monitoring and care, and discharged 2 days post procedure.This adverse event and product problem is being submitted because the verrata wire separated inside the patient.Additional intervention was performed; however, the separated tip was retained in the patient (stent).

• Brand Name: VERRATA 10185P
• 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: 16728699
• Report Number: 3008363989-2023-00017
• Device Sequence Number: 6673991
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(11)221110(17)251110(10)0302747857
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161887
• 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
• Report Date (Section B): 04/12/2023

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: 11/10/2025
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0302747857
• Was Device Available for Evaluation?: No
• 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: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White