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

Model Number	10185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6) facility declined to provide patient information due to confidentiality.No tests/laboratory data was available.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 coronary procedure where the manufacturer's device was used for diagnostic purposes, after crossing the lesion inside the body, the pd curve was unstable.There was no patient injury.Vessel: lad, occlusion: 50%, tortuousness: slightly additional information indicated no damage was observed during prep.After normalization and during delivering of the wire, the user felt some resistance.After removal from the patient the user noticed the tip was damaged, appearing almost separated.All parts of the device appeared to be present.The procedure was aborted; no other product was used.There were no adverse events and no additional medical or surgical intervention was performed.The patient was discharged as expected in "stable" condition.Visual and microscopic inspection and functional testing were performed on the returned device.The wire connector and torque device were not returned for investigation.The dome was corroded.The distal coil was observed to be stretched to 60mm in length but was intact.The core wire was broken and there was twisting of the wire at the fracture site location.Approximately 5mm of core wire extended past the sensor housing.The device passed zero testing.Due to the original connector not being returned, drift testing could not be performed.The core wire was twisted near the fracture site and a length of approximately 10mm was present.The probable cause of the reported wire unstable failure could not be determined.It should be noted a total of approximately 15mm of core wire was observed to be present.Per the instructions for use (ifu), the tip is extended 3cm (30mm) past the pressure sensor housing.Therefore, approximately 15mm of the core wire is missing.The core wire was broken and, as a result, the distal coil was significantly stretched.The probable cause of the observed damage was excessive mechanical strain during the procedure, as evidenced by the twisting of the core wire at the fracture site location.However, we were unable to conclusively determine through visual and microscopic inspection how the damage to the device occurred.The instructions for use (ifu) warns, never advance, torque or retract a pressure guide wire which meets significant resistance.The ifu also cautions, 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.The event is being reported in an abundance of caution because a piece of the core wire is missing and it cannot conclusively be determined when or where the separation occurred.

• 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: 7363051
• Report Number: 2939520-2018-00015
• Device Sequence Number: 18864100
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)201130
• 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): 01/31/2018

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: 11/30/2020
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50123526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1