MAUDE Adverse Event Report: PHILIPS VOLCANO REVOLUTION 45MHZ IVUS IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 89000

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).Attempts to obtain patient identifier have been unsuccessful.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.The implant or explant dates are not applicable to this device.

Event Description

This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a planned therapeutic coronary procedure the manufacture's catheter was used for diagnostic purposes.Resistance was encountered during removal and "the catheter broke inside of the patient".Target vessels: left main and proximal lad; radial access.Therapeutic outcome: left main stented.By report, no additional intervention was required to remove all portions of the manufacture's device.The patient did not experience an adverse event.Another same manufacture's device was used to complete the diagnostic portion of the procedure.There was no patient injury.The patient was discharged as expected; today's condition noted as good.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 product problem is being submitted because there is a potential for harm if the malfunction were to recur.

Event Description

This follow-up supplemental report #1 is being submitted to advise pertinent device analysis findings.

Manufacturer Narrative

Internal reference: (b)(4).The manufacture''s returned device was visually and microscopically inspected.There was a shaft separation 99.7 cm from the catheter tip.No portions of the device appeared to be missing.The probable cause of the reported damage is damage in use as evidenced by the shaft separation on the device.Device manipulation, impact and applied pressure associated with use and handling can affect the integrity of the device.We could not conclusively determine how the damage occurred.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.

• Brand Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8424577
• MDR Text Key: 139112462
• Report Number: 2939520-2019-00024
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)190831(10)0301501424(90)989609001881
• Combination Product (y/n): Y
• PMA/PMN Number: K080891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0301501424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 87