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 04/27/2022

Event Type  Injury  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Suspect products: not applicable for this device.Implant and explant date: not applicable for this device.The visions pv catheter was not returned for evaluation, thus no returned product investigation was performed.

Event Description

It was reported that during a diagnostic peripheral procedure in a slightly calcified proximal sfa, while advancing the visions pv.014p rx catheter, the tip broke off and was stuck on the non-manufacturer's guidewire.To assist with removal, a non-manufacturer's glide catheter was inserted into the patient.The catheter, guidewire, and glide catheter were removed as a system with no resistance noted.No piece of the catheter was retained in the patient.The patient was treated with a dcb.No patient injury reported.This adverse event and product problem is being submitted because the distal portion of the manufacturer's catheter separated in the patient, requiring additional intervention.

Manufacturer Narrative

Block d4 correction: updated serial number from (b)(6), lot number from 0301972700 to 0302193722, udi number from (b)(4), expiration date from 6/30/2022 to 3/15/2023.Block h3: the pv.014p catheter was returned in two pieces and visually and microscopically.The catheter separated at the guide wire exit port exposing the core wire and microcables, resulting in rough and sharp edges.The distal portion of the catheter was stuck on the non-manufacturer's's guide wire.No missing material detected.Block h4 correction: device manufacture date from 6/29/2020 to 3/15/2021.Block h6 correction: per the visual inspection, it was confirmed the catheter separated from the distal shaft, and not the distal tip.Component code updated from "3123" to "4721".Block h6: the probable cause for the missing material is unexpected damage in use.Strain, impact, and forces associated with use can affect the integrity of the device.It could not be conclusively determined when the cause of the damage occurred.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
• MDR Report Key: 14454981
• MDR Text Key: 292167623
• Report Number: 3008363989-2022-00029
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)210315(17)230315(10)0302193722
• 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: 05/19/2022

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 Expiration Date: 03/15/2023
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302193722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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" BMW GUIDEWIRE.; TERUMO: 5F PINNACLE INTRODUCER SHEATH.; TERUMO: SIZE UNK GLIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American