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

Model Number	10185
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.Facility declined to provide the information.No tests/laboratory data was available.The implant or explant dates are not applicable to this device.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported during a planned diagnostic coronary procedure, inside the body, after normalization, prior to measurement, resistance was met.When the device was removed from the patient for shaping again, the user found the proximal coil was stretched.Additional information provided the device had been inspected prior to the procedure with no visible defects observed.Resistance was encountered when crossing the lesion.When the device was removed from the patient, the user found that the wire tip was stretched but was not separated.A second of the same make and model of the manufacturer's device was used to successfully complete the procedure.Visual and microscopic inspections were performed on the returned device.The device was visually and microscopically inspected, damage was observed.The distal coil was observed to be stretched but was intact.The core wire was twisted and broken.The entirety of the core wire appeared to be present.The investigation was unable to verify the reported resistance failure as the device was damaged.The probable cause for the reported stretch failure is damage in use.The core wire was broken at the distal end, as a result, the distal coil was stretched.The damage likely occurred as a result of mechanical strain during procedure, as evidenced by the observed twisting near the core wire fracture sites.However, we were unable to conclusively determine how the damage occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This event is being reported as there is a potential for harm if the malfunction were to recur.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7656627
• Report Number: 2939520-2018-00064
• Device Sequence Number: 13483754
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)210331(10)0301424603(90)989609001211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131288
• 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): 06/04/2018

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: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0301424603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1