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	03/30/2018
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.Other relevant history: no information 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, outside the body before first use, during prep/loading, the pd curve was not displayed.Procedure was aborted.The wire was not zeroed or normalized.There was no patient injury.Visual and microscopic inspection and functional testing were performed on the returned device.Damage was observed on the device.The proximal coil was severed from the distal end of the wire; sharp edges were observed to be present.The microcables were observed to be severed and pulled from the distal end of the wire.It cannot be determined if all portions of the device are present.Sanguineous residue was present at the proximal coil.The wire was not recognized during zero testing and drift testing could not be conducted as a result.The customer stated that reported failure occurred "outside the body before first use, during prep/loading." additionally it was reported that no physical damage to the device was observed and no portion of the device became separated or detached.The observed damage likely occurred sometime after the device had failed but before it was received for decontamination.We were unable to conclusively determine when and how the damage occurred.The instructions for use (ifu) warns, never advance, torque or retract a pressure guide wire which meets significant resistance.The ifu precautions: do not use product that has been damaged in any way as this may result in vessel damage, inaccurate pressure measurements and/or poor torque response.The pressure guide wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Any time that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance.In some instances, the wire may kink and must be removed.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.Additionally, complaints are monitored by monthly complaint review board process.This malfunction is being reported because it could not be confirmed the damage occurred post-procedure; there is a potential for harm if the malfunction were to recur during clinical use.

• 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: 7526627
• Report Number: 2939520-2018-00039
• Device Sequence Number: 1529086
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)200630
• 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): 04/02/2018

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50102608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1