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

Model Number 3243

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

It was reported that burr detachment occurred.A rotapro was selected for use during a percutaneous coronary intervention (pci) procedure.During procedure, the device had abnormal sound in dynaglide mode and the rotapro burr detached 10cm distal to the burr after passing the y connector, burr was still inside the catheter.The devices were removed including the detached burr by pulling all device together.It was notice the shaft was kinked 10 cm proximal from the burr.The procedure was completed successfully with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy advancer device.Visual and microscope examination of the device revealed that the coil was kinked and stretched at the handshake connection.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated with no issues.The rotapro advancer was then connected to the rotapro control console system.The advancer was able to reach optimum speed without dropping speed with abnormal noise due to the kinked stretched coil.There were no detached components noted on the burr catheter or advancer.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that burr detachment occurred.A rotapro was selected for use during a percutaneous coronary intervention (pci) procedure.During procedure, the device had abnormal sound in dynaglide mode and the rotapro burr detached 10cm distal to the burr after passing the y connector, burr was still inside the catheter.The devices were removed including the detached burr by pulling all device together.It was notice the shaft was kinked 10 cm proximal from the burr.The procedure was completed successfully with another of the same device.There were no patient complications reported.

Event Description

It was reported that burr detachment occurred.A rotapro was selected for use during a percutaneous coronary intervention (pci) procedure.During procedure, the device had abnormal sound in dynaglide mode and the rotapro burr detached 10cm distal to the burr after passing the y connector, burr was still inside the catheter.The devices were removed including the detached burr by pulling all device together.It was notice the shaft was kinked 10 cm proximal from the burr.The procedure was completed successfully with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Update h6: device codes - changed detachment of device or device component a0501 device codes to break a0401 device evaluated by manufacturer: returned product consisted of the rotapro atherectomy advancer device.Visual and microscope examination of the device revealed that the coil was kinked and stretched at the handshake connection.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated with no issues.The rotapro advancer was then connected to the rotapro control console system.The advancer was able to reach optimum speed without dropping speed with abnormal noise due to the kinked stretched coil.There were no detached components noted on the burr catheter or advancer.Inspection of the remainder of the device presented no other damage or irregularities.

• 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 SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12295269
• MDR Text Key: 265630583
• Report Number: 2134265-2021-10091
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

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: 03/24/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0027028013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/26/2021; 02/09/2022
• Supplement Dates FDA Received: 09/13/2021; 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1