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

Model Number 89900

Device Problem Material Separation (1562)

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

Event Date 04/05/2019

Event Type  Injury  

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 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.

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 Description

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

• Brand Name: REFINITY ROTATIONAL IVUS CATHETER, SHORT TIP
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8576247
• MDR Text Key: 143941098
• Report Number: 2939520-2019-00034
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)210131(10)0301596695(90)989609000981
• Combination Product (y/n): Y
• PMA/PMN Number: K160583
• 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: 01/01/2005,04/05/2019

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
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WIRE, SNARE
• Patient Outcome(s): Other; Required Intervention