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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
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.By report, the device was in one piece after removal from the patient.Readings were successfully obtained.The physician met resistance while manipulating the device.The wire became stuck at the focal, eccentric calcified lesion.Another same manufacture¿s device was used to complete the procedure.Suspect products: no information available.The implant or explant dates are not applicable to this device.Address of preprocessor: not applicable for this device.Concomitant medical products: sheath introducer: terumo glide sheath 4-5fr, catheter: terumo diagnose catheter jl 4.0, 5fr.Initial reporter: (b)(6).The manufacturer's' returned device was visually, microscopically inspected and functionally tested.The probable cause of the reported failure could not be determined.No damage was observed that would result in the reported complaint.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
It was reported during a planned diagnostic coronary procedure, during removal, the physician could not retrieve the manufacturer's' device.The device was retrieved with another manufacturer's' microcatheter device.Vessel: left anterior descending artery (lad #6) with moderate stenosis, not tortuous, severe calcified this adverse event is being submitted because additional intervention via another manufacturer's' microcatheter device was required to retrieve the manufacture¿s device.There is a potential for harm if the malfunction were to recur.

• 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: 9376950
• Report Number: 2939520-2019-00056
• Device Sequence Number: 3066642
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)220630(10)0301681309(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): 10/28/2019
• 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: 06/30/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301681309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• 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: 10/28/2019
• Initial Report FDA Received Date: 11/26/2019
• 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