MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA PLUS PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
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.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.No information available.State/prefecture is (b)(6).Visual and microscopic inspection were performed on the returned device.The distal coil was stretched, and as a result, the core wire was broken in two parts.All pieces of the core wire were accounted for and no sharp edge was observed when viewed under the microscope.Manipulation and strain on the device can cause damage to internal components and can result the observed stretching in the distal coil and consequently core wire break, the damage to the device likely occurred during use.However, we were unable to conclusively determine when and how the damage occurred.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.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.(b)(6).
Event or Problem Description
It was reported during a planned diagnostic coronary procedure, the manufacturer¿s device could not cross the lesion in the lad [left anterior descending artery].The device was removed and the tip was reshaped.The physician attempted to cross the lesion again but could not.The device went into a small vessel near the target lesion and was trapped.The device could not be removed, therefore, the physician exchanged the diagnostic catheter with a guiding catheter.A goose neck snare was inserted into the guiding catheter and successfully retrieved the manufacturer¿s device.The distal portion was observed to be stretched.This adverse event is being submitted because additional intervention was required to retrieve the manufacturer¿s device.There is a potential for harm if the malfunction were to recur.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 9112941
• Report Number: 2939520-2019-00054
• Device Sequence Number: 11567931
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)220630(10)0301686481(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2019
• 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: 06/30/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301686481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005