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

Model Number	10185P
Medical Device Problem Codes	Stretched (1601); Material Split, Cut or Torn (4008); Sharp Edges (4013)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email.The implant or explant dates are not applicable to this device.Concomitant medical devices: microcatheter: medtronic: launcher 6fr.Ebu3.5.State/prefecture is (b)(6).Device evaluation anticipated, but not yet begun.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a planned therapeutic procedure, prior to reaching the lesion, the physician felt resistance, torque would not transmit to the tip and the manufacturer's device could not advance.Upon removal of the device the tip of the device was observed to be stretched but intact.There was no report of patient injury.Upon removal of another manufacturer's concomitant guide catheter (gc) device it was observed the tip of the gc was torn an estimated 2mm.The device was returned to the manufacturer for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because the manufacturer¿s returned device had rough edges.There is a potential for harm if the malfunction 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.Block h3: visual, microscopic inspection and functional testing were performed on the returned device.The distal coil was stretched and the core wire was broken and exposed.The exposed core wire was stretchered and still attached to the sensor housing.All parts of the device were present.Torque test could not be performed since the wire was damaged.The probable cause of the reported damage is excessive mechanical strain, as evidenced by the stretching of the distal coil and the separation of the core wire.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.H3 other text : placeholder.

• 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: 9703577
• Report Number: 2939520-2020-00004
• Device Sequence Number: 13944183
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)220930(10)0301744832(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): 01/20/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301744832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005