MAUDE Adverse Event Report: VOLCANO CORPORATION REVOLUTION ROTATIONAL IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.Patient information was declined by the facility.Further information provided, physical damage was observed when removing the device from the patient.There was no embolization, no injury and no decline in the status of the patient.The manufacturers device and (another manufacturers) guider were removed as a system.A second of the same make and model of the manufacturers device were used to complete the procedure.No tests/laboratory data was available.No physical product investigation was possible.To date, the device has not been returned to the manufacturer for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This complaint will be monitored as part of complaint data analysis.
Event or Problem Description
This case was investigated according to the manufacturer's policy.It was reported, the catheter broke into half during removal.The broken half of the catheter remained in the guider and both were removed.No troubleshooting was performed.Nothing was left in the patient.This event is being reported because the device was removed as a system.
Additional Manufacturer Narrative
Internal reference: (b)(4).Visual and microscopic inspection was performed.The device was received in two pieces with a shaft separation distal to the telescope strain relief.The shaft separation is at the marker band.The marker band is applied with heat over a solid shaft as a single piece.Abrasions were observed on the marker band at the shaft separation location.The probable cause of the reported shaft separation failure most likely occurred during bending or tension on the catheter.Device integrity can be affected by external factors such as device manipulation, impact, and applied pressure associated with use.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.This supplemental report (#1) is being submitted because the device was received and analyzed by the manufacturer.

• Brand Name: REVOLUTION ROTATIONAL IMAGING CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7630664
• Report Number: 2939520-2018-00057
• Device Sequence Number: 1432950
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)181231
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K080891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0035 50126395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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
• Patient Age: 79 YR
• Patient Weight: 78