MAUDE Adverse Event Report: VOLCARICA S.R.L. VOLCANO VISIONS PV .018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 86700

Device Problems Entrapment of Device (1212); Difficult To Position (1467); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.No tests/laboratory data was available.No information was available.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.During preparation in a peripheral therapeutic procedure, the customer stated the tip came off [separated] while physically stuck on the guidewire outside of the body.A second catheter was used to complete the procedure.No damage was observed during prep.The device was never introduced into the patient.No additional intervention was performed and patient did not experience any adverse events.There was no patient injury or harm.Vessel: iliac.Per decontamination the received device had multiple kinks and the scanner was missing.The returned device was inspected; the scanner was broken off at the connection to the weld legs and was missing.The esl remained intact.No adhesive residue was present on the remaining portion of the esl.Without the missing portion of the scanner, the probable cause of the reported failure could not be determined by the investigation.There were no abnormalities within the guidewire lumen that may have contributed to the reported failure.Strain, impact, and forces associated with use can affect the integrity of the device.It could not be determined when the cause of the failure occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.The event is being reported in an abundance of caution as there is a potential for harm if the event were to recur.

• Brand Name: VOLCANO VISIONS PV .018 DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; b37; alajuela, costa rica ; CS
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6248358
• MDR Text Key: 64722619
• Report Number: 2939520-2017-00002
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)181031
• Combination Product (y/n): N
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 0003 50081737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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