MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO PRE-CONNECTED EXCHANGEABLE BURR CATHETER AND BURR ADVANCING DEVICE; CATHETER, CORONARY, ATHERECTOMY

Model Number ROTAPRO 1.25MM

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/11/2021

Event Type  Injury  

Event Description

After coronary atherectomy as the md was attempting to pull back the shaft the burr and part of wire broke off.Burr was able to be extracted out of the body, however the wire was not able to be extracted.Fda safety report id # (b)(4).

• Brand Name: ROTAPRO PRE-CONNECTED EXCHANGEABLE BURR CATHETER AND BURR ADVANCING DEVICE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11831784
• MDR Text Key: 251363188
• Report Number: MW5101377
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2021
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: ROTAPRO 1.25MM
• Device Catalogue Number: H749393001250
• Device Lot Number: 26423677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Weight: 105