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

Model Number	89900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.The implant or explant dates are not applicable to this device.Concomitant medical products: no information available.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.
Event or Problem Description
It was reported during a therapeutic coronary procedure the manufacturer¿s catheter device could not move on another manufacturer¿s guidewire.The guidewire got tangled and the catheter got stuck.The catheter was removed with the guidewire.No damage was observed on the catheter.This adverse event is being submitted because another manufacturer¿s device malfunctioned requiring the manufacturer¿s device to be removed together, as a system.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.State/prefecture is (b)(6).The device was visually and microscopically inspected.The device passed the functional testing, and had no damage or faults that could lead to the reported failure, the complaint was not duplicated.As such, the probable cause of the reported failure could not be determined by the investigation.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 follow-up supplemental report #1 is being submitted to advise pertinent device analysis findings.

• Brand Name: REFINITY ROTATIONAL IVUS CATHETER, SHORT TIP
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8888474
• Report Number: 2939520-2019-00049
• Device Sequence Number: 3039253
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)200731(10)0301492208(90)989609000981
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 07/19/2019
• Report Date (Section F): 01/01/2005

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: 07/31/2020
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0301492208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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
• Date Report Sent to FDA: 01/01/2005