MAUDE Adverse Event Report: VOLCANO CORPORATION REFINITY ROTATIONAL IVUS CATHETER, SHORT TIP; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89900
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.Facility declined to provide the information.Additional information provided a second of the same make and model of the manufacture's device was used to successfully complete the procedure with no decline in the patients status.No tests/laboratory data available.The implant or explant dates are not applicable to this device.Visual and microscopic inspection were performed on the returned device.There were multiple kinks and twists in the distal shaft near the tip.Torque compression was observed on the drive cable near the transducer housing within the distal shaft.The drive cable was buckled and wound itself numerous times in the luer lock area of the connector assembly.The device was returned with a third-party guidewire stuck inside of it.The probable cause of the reported failure is due to multiple kinks and twists in the shaft distal tip of the returned device.Device manipulation, impact, and forces associated with use can affect the integrity of the device.It could not be determined when the observed damage occurred.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported, inside the body, while passing through the lesion at bifurcation of left circumflex artery (lcx #12), the user was unable to move the manufacturer's device over the guidewire (another manufacturer's device).The manufacturer's device was removed with the guidewire.Access location: femoral, vessel tortuosity: severe.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This event is being reported because the manufactures device and another manufacturer's device (guidewire) were removed as a system.

• Brand Name: REFINITY ROTATIONAL IVUS CATHETER, SHORT TIP
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7701029
• Report Number: 2939520-2018-00065
• Device Sequence Number: 13707003
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)200331(10)0301421426(90)989609000981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160583
• 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): 06/05/2018

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: 03/31/2020
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.289
• Device Lot Number: 301421426
• 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: 06/05/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: Required Intervention