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

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 02/14/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 311124996
• Report Number: 3008363989-2023-00010
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)230104(17)250104(10)0302794279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MFG UNK: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDEWIRE
• Patient Outcome(s): Required Intervention