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

Model Number	10185
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer's policy.By report, the doctor wired a side branch using a verrata pressure guide wire.During the procedure, the wire got stuck in the vessel.When the doctor tried to retrieve the wire, he saw that the distal segment was broken and sticking out in the aortic root of the patient.He tried to remove the distal part with a snare but was not able to retrieve it.The doctor decided to proceed to an open surgery.Even during the open surgery, it was not possible to remove the whole wire.By manual force it broke again and the distal part still remained in lcx (left circumflex artery).The lcx (left circumflex artery) was grafted with svg (saphenous vein graft).The patient is ok, as per normal for post-cabg.Same-day surgery which was uneventful.Transferred to local hospital in good condition.Patient was in hospital (normal length of stay) with no further complications.The patient is home and she's going to start (if not started already in fact) rehab after her surgery as standard procedure.Implant and explant dates: the implant or explant dates are not applicable to this device.Visual and microscopic inspection were performed on the returned device.Both the distal coil and core wire were broken and the distal ends of each were missing.The core wire was twisted and extended approximately 23mm past the sensor housing.The distal coil was stretched out and broken into three pieces.Approximately 21mm of the distal coil was extended past the sensor housing.The first piece of the separated distal coil was measured and a length of approximately 202mm was observed.The coil was also observed to be twisted at two different locations.The second piece of the separated distal coil was measured and a length of approximately 67mm was observed.The dome was not present.The distal coil and core wire were broken and the distal ends of each were missing.This damage likely occurred as a result of mechanical strain, as evidenced by the observed twisting near the core wire fracture site.The user reported that the device became stuck in the vessel and observed that the "distal segment was dislodged and sticking out in the aortic root of the patient." the instructions for use (ifu) warns never advance, torque or retract a pressure guide wire which meets significant resistance.The ifu further 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.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.
Event or Problem Description
It was reported the physician wired a side branch with the manufacturer's guidewire.The wire got stuck in the vessel, whereby the first physician asked assistance from another physician to retrieve the wire.When the second physician tried to retrieve the wire, the second physician saw the distal segment was dislodged and sticking out in the aortic root of the patient.Open surgery was needed to remove the distal part of the wire from the patient.Patient is home and starting rehab after her surgery as standard procedure.This event is being reported because surgical intervention was required to remove the device.

• 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: 6822858
• Report Number: 2939520-2017-00071
• Device Sequence Number: 67996
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)200630
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 07/28/2017

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: 06/30/2020
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50103833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/25/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 77