MAUDE Adverse Event Report: VOLCARICA S.R.L. VERRATA PLUS PRESSURE GUIDE WIRE 185CM; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 10185P

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Event Description

While attempting to hookup the volcano verata to the machine, we kept receiving error messages.(poor/weak cable connection code 108 and sot wire positioning) the equipment never touched the patient at any time.New verata opened and no complications occurred.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE 185CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCARICA S.R.L.; khalid s. raja; 3721 valley centre drive, suite 500; san diego CA 92130
• MDR Report Key: 7024463
• MDR Text Key: 91822937
• Report Number: 7024463
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

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: Unknown
• Device Model Number: 10185P
• Device Catalogue Number: 10185P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR