MAUDE Adverse Event Report: VOLCARICA S.R.L. VISIONS PV.018 DIGITAL IVUS CATHETER; CEMENT, BONE, PRE-FORMED, MODULAR, POLYMERIC, VERTEBROPLASTY

Model Number 86700

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

While using ivus inner portion of ivus catheter became lodged to the inner wire being used.Wire had to be cut with broken portion of ivus stuck to wire.

• Brand Name: VISIONS PV.018 DIGITAL IVUS CATHETER
• Type of Device: CEMENT, BONE, PRE-FORMED, MODULAR, POLYMERIC, VERTEBROPLASTY
• Manufacturer (Section D): VOLCARICA S.R.L.; 9965 federal dr; colorado springs CO 80920
• MDR Report Key: 11752317
• MDR Text Key: 248180095
• Report Number: 11752317
• Device Sequence Number: 1
• Product Code: OBL
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)220430(10)0301921704(90)300004659341
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86700
• Device Lot Number: 0301921704
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27375 DA
• Patient Weight: 50