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	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Facility declined to provide patient information.No information available.The implant or explant dates are not applicable to this device.(b)(6).Device was not returned for investigation.
Event or Problem Description
It was reported during a planned diagnostic coronary procedure the physician attempted ifr pullback at lcx [left coronary artery] #15 and the manufacturers guidewire (gw) got stuck.The physician unsuccessfully attempted to attach an extension on the proximal end of gw and cut with surgical scissors 10cm from proximal edge.The physician unsuccessfully attempted to insert the gw into a balloon catheter.Finally, the physician successfully inserted the gw into a microcatheter and was able to advance.This report is being submitted because additional intervention was required to remove the manufacturers device.There is a potential for harm if the event were to recur.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to advise pertinent device analysis findings.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Visual, microscopic inspection and functional testing were performed on the returned device.Two third-party devices were returned with the device.The device was not stuck in either third-party devices.The device was returned in two sections, one attached to the locking core and the other attached to the rest of the components.It was observed the device is missing hypotube material.Two third party catheter devices were returned with the device.These catheters were inspected, but no conclusive evidence of the presence of the missing hypotube material was found.The probable cause of reported failure is damage during use.Inappropriate manipulation of the wire cause damage to internal components.Reportedly, the physician cut the device with surgical scissors.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).

• 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
• MDR Report Key: 8872491
• Report Number: 2939520-2019-00048
• Device Sequence Number: 2390596
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)220331(10)0301630878(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,Followup
• Report Date (Section B): 06/11/2019
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301630878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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