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 01/20/2023

Event Type  Injury  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.The visions pv.014p rx catheter was not returned for evaluation, 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.

Event Description

It was reported that a visions pv.014p rx catheter was used in a diagnostic peripheral procedure on a patient with congenital neck muscle problem that would pinch the internal jugular vein when the neck is turned.A non-philips introducer sheath was inserted in the right common femoral vein, a non-philips guide wire was placed in the right internal jugular vein, visions catheter placed past the intended location, and ivus was performed.After the second ivus run, during pullback the catheter got stuck on the extra strength guidewire.While trying to get the catheter in the sheath, some degree of force was applied.The physician felt elongating of the catheter and eventually snapped, and unable to get it in the pre-existing sheath after moving it to the ivc.A 8fr sheath was placed in the left common femoral vein and with a snare, the separated portion was removed as a unit.Upon removal, it was noticed that the catheter separated at the rx exit port.The patient was discharged the same day with no injury reported.This adverse event and product problem is being submitted due to the visions shaft separation, requiring intervention (snare).

Manufacturer Narrative

The visions pv.014p rx catheter was returned in 2 pieces.The catheter separated at the distal shaft with a non-philips guidewire stuck on the separated distal portion of the catheter.The distal portion (including bent distal tip, scanner body, and a portion of the distal shaft) measured approx.33 cm.The proximal portion (including a portion of the distal shaft, proximal shaft, connector cable, and connector) measured approx.149 cm.At the location of the separation, the microcables were exposed with sharp edges of non-malleable material.Additionally, the core wire was exposed with a sharp edge of non-malleable material.No missing material was detected.The probable cause of the shaft separation is damage during use.Strain, impact, and forces associated with use can 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: 16343491
• MDR Text Key: 309262199
• Report Number: 3008363989-2023-00004
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)221013(17)241013(10)0302726107
• 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,Followup
• 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: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302726107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• 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: ASAHI: 0.014" MONGO GUIDE WIRE.; TERUMO: 5F INTRODUCER SHEATH.
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White