MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .014P RX; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

Device Problem Material Separation (1562)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

It was reported that a visions pv.014 rx catheter was used in a therapeutic peripheral procedure in the mid sfa.During pullback, resistance was noted and the catheter separated, but remained intact to the non-philips guidewire.The catheter and guidewire were removed as a unit with no additional intervention required.Angio confirmed that no piece of the catheter was left inside the patient.Patient was discharged with no injury reported.This product problem is being submitted because the visions catheter separated inside the patient.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.The visions catheter was returned in two pieces.The distal shaft was intact to a non-philips guidewire.At the location of the separation, the microcables were broken and exposed with sharp edges observed.The distal tip was deformed and the inner member was bunched up.No missing material was detected.The probable cause for the separation is unexpected damage during use.Device manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.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 .014P RX
• 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 ; 858720-406
• MDR Report Key: 16392057
• MDR Text Key: 309873042
• Report Number: 3008363989-2023-00006
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)220824(17)240824(10)0302682871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152829
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302682871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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: ABBOTT: 0.014" COMMAND GUIDE WIRE.; TERUMO: 6F DESTINATION INTRODUCER SHEATH.