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

Model Number 86700

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturers policy.Attempts to obtain patient information have been unsuccessful.Other tests: no information available.The implant or explant dates are not applicable to this device.Device available for eval: not applicable for this device.(b)(4).Recall: do not apply to this submission.

Event Description

This case was reviewed and investigated according to the manufacturers policy.It was reported during a planned diagnostic peripheral procedure, the tip of the transducer came off the manufacturers device during pullback.All portions were removed from the body in one piece on another manufacturers guidewire.The procedure was completed with a laser device with no reports of adverse events or injury.The returned device was visually and microscopically inspected, the distal floppy tip and scanner body were separated from the device and returned separately on a third party wire.Small amounts of adhesive material was missing and a portion of expanded single lumen (esl) material was missing; irregular edges were observed.The probable cause of the reported tip of the transducer came off during pullback failure is the device was damaged from use.The observed missing esl and adhesive material is a result of the scanner body being separated from the catheter device.Strain, impact, and forces associated with use can affect the integrity of the device.This product problem is being submitted in an abundance of caution as it could not be conclusively determined when the separation occurred.There is a potential for harm if the separation were to recur.

Manufacturer Narrative

Block g3.Corrected initial mdr aware date from 11/23/2020 to 11/17/2020.

Manufacturer Narrative

Block h6: added codes 3123 (tip) and 2199 (no health consequences or impact).

• 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: 11562617
• MDR Text Key: 249222635
• Report Number: 2939520-2021-00011
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)211231(10)0301816466(90)989609002431
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

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 Expiration Date: 12/31/2021
• Device Model Number: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 0301816466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 06/06/2021; 06/06/2021
• Supplement Dates FDA Received: 06/18/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1