MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Facility declined to provide patient information.Suspect products: no information available.The implant or explant dates are not applicable to this device.Concomitant medical products: no information available.Initial reporter: state/prefecture is (b)(6).The returned device was visually and microscopically inspected.There were bends observed along with a kink at the end of the tip of the distal coil.The probable cause of the reported failure is a kink in the distal coil.Device manipulation, impact and applied pressure associated with use and handling can affect the integrity of the device.Remedial action/correction #: do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer¿s policy.The customer reported during a planned therapeutic coronary procedure, the device became stuck and could not be retrieved.The device was shaped and went into a narrow branch before reaching the target lesion (right coronary artery) for diagnosis.The tip of the device became stuck.A microcatheter was inserted over the manufacturer's device allowing it to be released and retrieved.The tip unravel slightly after retrieval.A second of the manufacturer¿s same device was used to complete the procedure.This adverse event is being submitted because additional intervention was required to remove the manufacturer's device.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in g4, the date received by manufacturer (becomes aware date).
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the initial report submitted 07/23/2020 had an inadvertent entry error of 06/23/2020.Correct date is 06/19/2020.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 the alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
This adverse event and product problem is being submitted because additional intervention was required to remove the manufacturer's device.
Additional Manufacturer Narrative
Block g: the supplemental follow-up #1 submitted 03/7/2021 had an inadvertent entry error of 02/05/2020.Correct date is 06/19/2020.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 10312835
• Report Number: 2939520-2020-00019
• Device Sequence Number: 19726385
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)221231(10)0301810854(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K161887
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2020
• Report Date (Section F): 01/01/2005

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: 12/31/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301810854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 08/24/2021; 06/19/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 03/07/2021; 08/24/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005