MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAGLIDE; CATHETER, CORONARY, ATHERECTOMY

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/22/2019

Event Type  No Answer Provided  

Event Description

Pharmacy tech found vial on the counter in the cath lab which looked like propofol.It was found to be rotaglide, a guidewire lubricant used in cath lab cases, marketed as a device.The propofol vials and rotaglide vials and appearance of the product (milky, white liquid) look extremely similar and could be mistaken easily.

• Brand Name: ROTAGLIDE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8479558
• MDR Text Key: 141015352
• Report Number: MW5085545
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 03/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Patient Sequence Number: 1