MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .035 (NON-HOSPITAL); CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	81234
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block g2: user facility report # mw5116099.Blocks h3 & h6: the visions pv.035 catheter was not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Blocks h7 & h9: do not apply to this submission.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 an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that the patient was under sedation with moderate anesthesia.The visions pv.035 catheter was flushed and calibrated prior to loading over a guidewire.Upon advancing the catheter inside the patient, no image was displayed on the monitor.The procedure was aborted without completing the ivus evaluation.The patient requires an additional invasive procedure to complete the evaluation at a later date.This adverse event is being reported because the patient was under sedation, and unable to complete the procedure.This resulted in a delay of the procedure.

• Brand Name: VISIONS PV .035 (NON-HOSPITAL)
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 16857551
• Report Number: 3008363989-2023-00022
• Device Sequence Number: 12893656
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(11)221024(17)241024(10)0302733648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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: 10/24/2024
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0302733648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MFG AND SIZE UNK: GUIDE CATHETER; MFG AND SIZE UNK: GUIDE WIRE; MFG AND SIZE UNK: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown