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

Model Number H749394671500

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

Unable to advance over wire due to kink in cable near main motor device.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 16681191
• MDR Text Key: 312682236
• Report Number: 16681191
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729999577
• UDI-Public: (01)08714729999577(17)240522(10)
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749394671500
• Device Catalogue Number: H749394671500
• Device Lot Number: 29455507
• 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: 03/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White