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

Model Number	89900
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (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 initially reported the image disappeared on the manufacturer's device.A second of the same make and model of the manufacturer's device was used to successfully image the right coronary artery (rca).There was no patient injury and no adverse events.The device was visually and microscopically inspected.It was observed that there were kinks and bends along the proximal shaft of the device.The braided shaft was exposed but still intact.No sharp edges were protruding and no sanguineous material was present.The extension shaft was separated from the drive cable in the luer lock area of the connector assembly.The reported failure (incomplete image) could not be duplicated.The probable cause of the reported failure is due to the observed kinks and shaft separation on the returned device.It could not be determined when the observed damage occurred.The probable cause of the observed failure (exposed braided shaft) could not be determined.The user reported no damage was observed on the device after removal and when preparing the device for return.The device integrity can be affected by external factors such as device manipulation, impact, and applied pressure associated with use.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: 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: 7825492
• Report Number: 2939520-2018-00085
• Device Sequence Number: 1143676
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)200430(10)0301442674(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): 07/03/2018

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: 04/30/2020
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0301442674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1