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

Model Number 39467-125

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Gas/Air Leak (2946); Material Integrity Problem (2978); Noise, Audible (3273); Intermittent Loss of Power (4016)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 09/23/2022

Event Type  Injury  

Event Description

It was reported via user facility or voluntary medwatch #: (b)(4) that st elevation occurred.During a percutaneous coronary intervention (pci) procedure in the right coronary artery (rca), the rotapro stalled and lost pressure.A whistling sound was noted and it appeared to have a leak in the tubing delivering nitrous oxide.Blood appeared in the advancer handle and the gas was turned off.Air, saline and blood was noted to leak from the advancer.The patient developed st elevation while device was in use.The device was removed without known harm to the patient.Another rotapro was used to continue with the procedure.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device found that the sheath was able to be moved along the coil, and that blood was present within the sheath and advancer.In order to determine the nature of the sheath damage, the burr housing was dismantled.It was found that the sheath had separated within the burr housing.Functional testing was performed by connecting the rotapro device to the liquid infusion line.When liquid was advanced through the device, a leak was identified at the damaged portion of the sheath in accordance with the reported events.Further 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 [ablation button] was pressed, the device stalled and would not run due to the blood within the device.The sound of air escaping the device was heard during the stall in accordance with the reported abnormal noise and air leak.Product analysis confirmed the reported stall, noise, and air leak, as the device stalled and would not run due to the presence of blood within the device.The abnormal noise of air escaping the device was heard during the device stall.The reported blood and saline leak was confirmed, as a sheath separation was identified within the burr housing.Fluid leaked from the hole in the sheath during functional testing.The reported st segment elevation was not able to be confirmed, as clinical circumstances were unable to be replicated.Corrected: b1 adverse event/product problem, b2 outcomes attrib to adv event, b7 other relevant history, e1 initial reporter first name and initial reporter last name, e3 init rptr also sent rep to fda.

Event Description

It was reported via user facility or voluntary medwatch #: 3600840000-2022-8093 that st elevation occurred.During a percutaneous coronary intervention (pci) procedure in the right coronary artery (rca), the rotapro stalled and lost pressure.A whistling sound was noted and it appeared to have a leak in the tubing delivering nitrous oxide.Blood appeared in the advancer handle and the gas was turned off.Air, saline and blood was noted to leak from the advancer.The patient developed st elevation while device was in use.The device was removed without known harm to the patient.Another rotapro was used to continue with the procedure.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15712705
• MDR Text Key: 302825247
• Report Number: 2124215-2022-44802
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0027235181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 69 KG