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

Model Number 86700

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.Additional information stated, resistance was encountered upon attempting to remove the catheter over the wire after taking measurements.The dr.Was able to use an uninflated.035 balloon to run otw (over the wire) and over the catheter tip, to capture the catheter tip successfully.All portions (wire, catheter and balloon) were successfully retrieved.The rapid exchange portion of the catheter tore from excessive force required to pull back the catheter as it was binded to the wire.Dr.Put same wire back into patient to complete the case with a pta and final venogram.There were no patient complications.No tests/laboratory data was available.Relevant history: no information was available.Suspect products: no information available.The implant or explant dates are not applicable to this device.Device was not returned to manufacturer for analysis.Device was not returned to manufacturer for analysis.Removal number: do not apply to this submission.The instructions for use (ifu) cautions: do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

It was reported the manufactures catheter device was stuck on another manufacturers wire device during removal.The tip of catheter separated on the wire, another manufacturers balloon device was used to remove the tip.The patient condition is reported as "fine".This adverse event is being submitted because additional intervention was required to remove the separated portion of the manufacturer's device.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block d10: device was returned to manufacturer on 12-28-2020.However, due to a serial number discrepancy it was not until new information was received on 01-11-2021 that tied the device to this complaint.Block h3: the returned device was visually and microscopically inspected.The distal floppy tip and scanner body were returned separated from the device.The shaft material was torn, stretched, twisted and material was missing.The probable cause of the reported failure is damage from use.Per additional information, the tip of the device separated and remained on (another manufacturers) guidewire inside the patient and was successfully retrieved by the physician.The rapid exchange portion of the the manufacturers device tore (split like a peel-away) from excessive force required to pull back as it was bound to the guidewire.The instructions for use (ifu) precautions: ¿do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully removed both the wire and catheter and do not use.¿ 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 the alleged death or deterioration in the state of the health of any person.

Event Description

This follow-up supplemental report #1 is being submitted to correct the serial# and udi# from the initial report submitted on 23 december 2020, and to advise pertinent device analysis findings.

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11064693
• MDR Text Key: 223389804
• Report Number: 2939520-2020-00038
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)220930(10)0302022299(90)300004659341
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: 09/30/2022
• Device Model Number: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 0302022299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO GLIDEWIRE .018; TERUMO GLIDEWIRE .018
• Patient Outcome(s): Required Intervention