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

Model Number	85900PST
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Initial reporter & report source: country is (b)(6).The eagle eye platinum st catheter was infectious and not returned for evaluation, thus no returned product investigation was performed.
Event or Problem Description
It was a reported that during a therapeutic peripheral procedure, the manufacturer's catheter got stuck on the non-manufacturer's guide wire due to a kink in the guide wire.The physician cut the proximal end of the catheter as an attempt to remove the catheter from the guide wire without success, thus was removed as a unit.The procedure was completed with another device.The patient was discharged as expected with no patient injury reported.The adverse event is being submitted because the catheter was stuck on the guide wire and additional intervention was performed.

• Brand Name: EAGLE EYE PLATINUM ST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• MDR Report Key: 12708172
• Report Number: 3008363989-2021-00019
• Device Sequence Number: 11922543
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)210722(17)230722(10)0302342264
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2023
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0302342264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/27/2021
• 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: ASAHI: GRADIUS GUIDE WIRE, SIZE UNK; TERUMO: DESTINATION SHEATH/GUIDE SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention