MAUDE Adverse Event Report: PHILIPS VOLCANO EAGLE EYE PLATINUM ST; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900PST

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

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.No information available.Not applicable for this device.The implanted or explanted dates are not applicable to this device.Not applicable for this device.Country is (b)(6).The device was visually and microscopically inspected.The scanner body and tip were detached with sharp edges observed on the proximal body where the scanner detached from the device.The probable cause of the reported failure is damage in use as evidenced by the scanner body damage and detachment.Device manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

It was reported that during a diagnostic peripheral procedure, an error message "catheter fault detected " appeared.Due to the error message, the catheter was retrieved.The angiogram confirmed the distal tip separated and retained in the patient.A snare was used and the distal tip was retrieved.No patient injury reported.This adverse event and product problem is being submitted due to the tip separation requiring intervention.

Manufacturer Narrative

Internal reference: (b)(4).Block h6: added codes 3123 (tip) and 4641 (unexpected medical intervention).In the initial mdr, code 2199 (no health consequences or impact) was identified.However, upon further review, code 4641 is now being populated to most accurately capture this event.

• Brand Name: EAGLE EYE PLATINUM ST
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11761228
• MDR Text Key: 249223370
• Report Number: 2939520-2021-00022
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)210111(17)230111(10)0302129855
• Combination Product (y/n): Y
• PMA/PMN Number: K143701
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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: 01/11/2023
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0302129855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASAHI: GLADIUS GUIDE WIRE, SIZE UNK; MEDIKIT: 6F PARENT CROSS SHEATH/GUIDE
• Patient Outcome(s): Required Intervention