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 05/22/2023

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 rcia.During removal, the catheter became stuck on a non-philips guidewire.Due to a knot on the guidewire, the catheter distal tip separated, but remained intact to the guidewire.The catheter and guidewire were removed as a unit with no additional intervention required.No patient injury reported.This product problem is being submitted because the visions distal tip 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.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions pv.014p rx catheter was not returned 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.

Manufacturer Narrative

Block h3: the visions pv.014p rx catheter was returned in two pieces.Visual inspection found the catheter separated at the rx bond on the distal shaft, with no missing material.At the location of the separation, the microcables and the core wire were exposed with sharp edges of non-malleable material.Additionally, a kink was observed at the proximal shaft.Block h6 correction: based on the device evaluation, the catheter separated at the distal shaft, and not the distal tip.Component code updated from "3123" to "4721".Block h6: 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 kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-406
• MDR Report Key: 17122326
• MDR Text Key: 317309445
• Report Number: 3008363989-2023-00025
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)230412(17)250412(10)0302878028
• 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: 07/11/2023

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: 0302878028
• 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: 06/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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: ASAHI: 0.014" GRAND SLAM GUIDEWIRE.; COOK: 6F FLEXOR CHECK FLO INTRODUCER SHEATH.
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White