MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	86700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a visions pv.018 catheter was used in a fistulagram procedure.When the catheter was removed from the patient, a missing distal tip was noted.Fluoroscopy identified the distal tip was still over the wire inside the patient¿s mid-upper arm level.The wire was gently retracted with the distal tip into the sheath.Compression was applied for hemostasis on the fistula and an incision was made at the level of the sheath.The sheath was removed and the distal tip was fished out using surgical instruments.The incision was closed after all materials were removed.Fluoroscopy confirmed no piece was retained inside the patient.The patient was discharged as expected with no injury reported.This adverse event and product problem is being submitted due to the tip separation requiring surgical intervention.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.The visions pv.018 catheter was discarded by the facility, thus no returned product investigation was performed.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.

• Brand Name: VISIONS PV .018 CATHETER
• 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
• MDR Report Key: 16526490
• Report Number: 3008363989-2023-00010
• Device Sequence Number: 5259444
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)230104(17)250104(10)0302794279
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K150442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2025
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302794279
• 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: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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 UNK: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown