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

Model Number	89900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
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.Facility declined to provide patient information.The implant or explant dates are not applicable to this device.State/prefecture is (b)(6).Device not received for evaluation.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
During a planned therapeutic coronary procedure, inside the body, while passing through the lesion the tip of the manufacture¿s catheter device separated in the patient when they attempted to go through stent strut of cypher stent, which was implanted 10 years ago, and deliver to the lcx.The catheter was observed to be stuck.A snare was inserted from left femoral and the catheter was removed with the snare.However, the catheter tip was separated and found in left anterior tibial.The physician decided no additional intervention to remove this tip and left it in the vessel.This adverse event is being reported because the tip of the manufacture¿s device separated and additional intervention was required to remove the device.
Additional Manufacturer Narrative
Internal reference: 70679.The returned device was visually and microscopically inspected and damage was observed.The distal shaft was stretched and broken, the catheter tip was not present.The transducer and the pzt were intact.Sanguineous material was observed on the distal shaft.The connector assembly was not present.The probable cause of the reported failure is damage not expected during routine use as evidenced by missing tip and connector assembly.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.It could not be determined when the cause of the failure 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.
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: 8576247
• Report Number: 2939520-2019-00034
• Device Sequence Number: 2172815
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)210131(10)0301596695(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): 04/05/2019
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0301596695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WIRE, SNARE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Date Report Sent to FDA: 01/01/2005