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

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).No patient information provided to date.The implant or explant dates are not applicable to this device.

Event Description

This case was reviewed and investigated according to the manufacturer¿s policy.It ws reported during a therapeutic peripheral procedure, while the customer was loading the catheter onto the wire during preparation before first use, the tip of the manufacture¿s device fell off prior to going inside the patient.The physician opted to proceed to use the catheter and was able to complete the procedure with no issues.No patient injury occurred.Damage was observed on the manufacture¿s returned device.A part of the floppy tip was returned separated from the device.The device and tip were visually and microscopically inspected.Stretching was observed at the sites of separation.All portions of the device were accounted; no portions were missing.The probable cause of the reported ¿tip fell off¿ failure is damage during handling, likely from an excessive pulling force as evidenced by the stretching observed at the separation site.Strain, impact, and forces associated with use can affect the integrity of the device.However, it was not possible to determine when and how the failure occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because the physician opted to use the manufacture¿s device off-label.There is a potential for harm if the malfunction were to recur.

• Brand Name: VOLCANO VISIONS PV .018 DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 8516728
• MDR Text Key: 145646616
• Report Number: 2939520-2019-00030
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)201130(10)0301563893(90)989609002431
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/22/2019

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: 11/30/2020
• Device Model Number: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 301563893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2018
• 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