MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA; TRANSDUCER, PRESSURE, CATHETER TIP

Catalog Number 10185

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104); Disconnection (1171); Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Type  malfunction  

Event Description

After diagnostic catheterization proceeded to measure fraction flow reserve (ffr) of the left anterior descending coronary artery (lad) diagonal then proceeded on to intervention.The distal end of the wire was disconnected from the volcano adapter.They then went on to load a 2.25 x12 boston scientific emerge balloon on to the ffr wire which did seem a little bit difficult to advance the balloon, so it was removed and wiped off with heparinized saline.The tip of the balloon seemed bent so they got a new balloon (bsc 2.25x12mm emerge) which seemed to load more easily, it was advanced and inflated in the vessel, removed and another balloon was used which seemed to be a little difficult to load (bsc 2.25x12mm balloon) but it did load appropriately.Then a 2.5x16mm boston synergy stent was advanced and deployed, the delivery system was also removed with no issue, both wires were also removed.Final pictures were taken and guide catheter was removed.After sheath removal patient's bp dropped and his condition deteriorated and became unconscious.Femoral access was gained to re-check the coronaries, all while patient started to improve, the dr was able to visualize what looked to be a small wire floating in the circulation.It then became mobilized with next injection which lodged it into the distal end of the left atrial branch of the circ.An echo was done and no effusion or dissection, cv surgery consulted initially as it was unclear what etiology of symptoms were at the time and wanted them on standby, but ended up not required.The patient recovered.After thorough look and investigation of the ffr volcano wire it was determined that the distal end of the wire (the end where devices are loaded onto) it looked like a piece of the wire was broke off and possible into the patient via balloon.First emerge balloon reported in device information not as defective but became defective due to the issue with the wire.

• Brand Name: VERRATA
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr; ste 500; san diego CA 92130
• MDR Report Key: 6236295
• MDR Text Key: 64272711
• Report Number: 6236295
• 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: 12/01/2016,12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR