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

Model Number 39467-150

Device Problem Device Remains Activated (1525)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 02/25/2022

Event Type  Injury  

Event Description

It was reported that vessel perforation occurred.A percutaneous coronary intervention was being performed using a 1.50mm rotapro for treatment.During ablation, the activate button on the advancer was pressed to shut down the burr.However, the burr continued to run despite pressing the button.This lead to the patient's vessel to perforate.Pericardiocentesis was then performed in order to treat the vessel perforation, and a stent was used to cover the perforation.The procedure was completed successfully, and the patient's status post-procedure was good.

Manufacturer Narrative

Product analysis by mfr: the returned product consisted of the rotapro atherectomy system.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.The device was able to active and deactivate with no issues.Product analysis could not confirm the reported events, as the device was able to activate and deactivate as intended and was able to reach and maintain optimal rpm with no resistance or issues.The reported perforation could not be confirmed as clinical circumstances could not be replicated.

Event Description

It was reported that vessel perforation occurred.A percutaneous coronary intervention was being performed using a 1.50mm rotapro for treatment.During ablation, the activate button on the advancer was pressed to shut down the burr.However, the burr continued to run despite pressing the button.This lead to the patient's vessel to perforate.Pericardiocentesis was then performed in order to treat the vessel perforation, and a stent was used to cover the perforation.The procedure was completed successfully, and the patient's status post-procedure was good.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13859954
• MDR Text Key: 287665429
• Report Number: 2134265-2022-03215
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0028533723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention