MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .014P RX; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Facility declined to provide patient information.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.No information available.The returned portions of the device was visually and microscopically inspected.The device was received in two (2) separate pieces in two (2) separate packages.The device was observed to be broken at the distal shaft and a third-party device was returned stuck to the proximal shaft.The proximal shaft and distal shaft were wavy, twisted, and kinked.The guidewire exit port was intact but stretched.The microcables were detached near the rx bond and contained within the distal shaft.The core wire was intact and contained with the distal shaft.A portion of the detached microcables was observed within the distal shaft.The distal end of the broken distal shaft was stretched, resulting in an irregular edge.The inner member was exposed out of the distal shaft, was stretched, and had an irregular edge.The distal tip of the device was intact and in good condition.A gap was observed between the scanner body and distal tip.The entirety of the distal tip and scanner body was intact; no missing piece was observed.The remaining portion of microcables were still attached to the scanner weld legs.Portions of the distal shaft were flattened.The proximal end of the distal shaft was stretched and tied in a knot.The probable cause of the reported ¿the tip of the device was sheared off¿ failure is mechanical strain, as evidenced by the stretched inner member and distal shaft with both pieces of the device.Strain, impact, and forces associated with use can affect the integrity of the device.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

It was reported during a planned diagnostic peripheral procedure, the tip of the manufacturer's device was sheared off.The device was plugged into the system, flushed, advanced through the sheath, to iliacs.The device became stuck, physician removed the devices as a system at which time the tip broke off in the radial artery.The patient was transported to the hospital via ambulance to have the separated portion surgically removed.This adverse event is being submitted because the manufacture's device separated in the patient.Additional medical and surgical intervention, and hospitalization were required.

• Brand Name: VISIONS PV .014P RX
• 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: 10223227
• MDR Text Key: 201202903
• Report Number: 2939520-2020-00018
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(17)220228(10)0301866285(90)989609001091
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K152829
• 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: 01/01/2005,06/02/2020

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: 02/28/2022
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0301866285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• 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: 06/02/2020
• Initial Date FDA Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention