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

Model Number 86700J

Device Problem Material Separation (1562)

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

Event Date 03/07/2019

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.Facility declined to provide patient information.The implant or explant dates are not applicable to this device.(b)(6).Device was not returned for investigation.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

It was reported during a planned therapeutic peripheral procedure the shaft of the manufacture's device separated.The device was used at the isr lesion in right cia.The transducer stuck at the lesion at the second pullback and could not be removed.Finally, the catheter could be removed from the patient and was found the distal portion from the transducer was missing.It was in the patient and the portion was retrieved from the patient with goose neck snare wire body under fluoroscopic-guide.This report is being submitted because the manufacture's device separated and required additional intervention to remove portions of the device.There is a potential for harm if the event were to recur.

Manufacturer Narrative

Internal reference: (b)(4).The returned device was visually and microscopically inspected and damage was observed.The catheter was separated in two sections at the joint between the expanded single lumen (esl) and the scanner.Sanguineous material was observed at the separation section, missing material of the expanded single lumen (esl) was observed on this section, also rough edges.The remaining catheter shaft was intact.By report, the device was stuck and a snare was used to free the device.Though we cannot conclusively determine when and how the failure occurred, strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.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.

• 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
• MDR Report Key: 8486948
• MDR Text Key: 141040679
• Report Number: 2939520-2019-00028
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002794
• UDI-Public: (01)00845225002794(17)200930(10)0301514563(90)989609001011
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/07/2019

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: 09/30/2020
• Device Model Number: 86700J
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0301514563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• 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: 03/07/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1