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

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 10/29/2020

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.The implant or explant dates are not applicable to this device.Device evaluation: not applicable for this device.Remedial action and removal #: 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.

Event Description

It was reported during a diagnostic procedure the manufacturers device was advanced to the lesion and the tip of the device broke off in the patient.They were able to retrieve the broken piece with endoscopic forceps.A second of the same manufacturers device was used to finish the procedure.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 b3: correction: the initial report submitted 11/12/2020 had an inadvertent entry error of 10/30/2020.Correct date is 10/29/2020.Block h3: the device was visually and microscopically inspected, damage was observed.A portion of the distal floppy tip was separated and not returned for investigation.A remaining portion of the distal floppy tip was damaged but still intact to the device.The damaged distal floppy tip was stretched and slightly flared out, presenting an irregular edge; the material is malleable.The scanner body (transducer) was intact and still attached to the device.The probable cause of the reported tip separation is damage in use, likely from an excessive pulling force, as evidenced by the stretched material observed at the distal end of the damaged floppy tip.Block h10: the manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.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 advise pertinent device analysis findings and to correct an inadvertent entry error in b3, date of event.

• 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: 10832791
• MDR Text Key: 216135727
• Report Number: 2939520-2020-00033
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)220930(10)0302022300(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: 11/04/2020

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: 0302022300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention