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

Model Number 39467-150

Device Problems Entrapment of Device (1212); Obstruction of Flow (2423); Output Problem (3005); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

It was reported that the rotapro burr became stuck on the rotawire.A 1.50mm rotapro and a rotawire drive were selected to be used for procedure.The rotapro was prepped and platformed at 200,000rpm outside the patient.During procedure, the advancer dynaglide mode button did not respond unless it was pressed firmly and strongly.The rotation speed did not sound like 200,000rpm, the sound was a little closer to a low speed, even though, it was set to 200,000rpm.There was abnormal sound and the burr became stuck on the rotawire.Then, when the physician checked the flush lumen it was stopped as if it was clogged.There was resistance encountered during removal.The rotapro and the rotawire were removed together as one unit from the patient.The procedure completed successfully with another device.There were no patient complications and the patient was good post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The device was received with the rotawire used in the procedure with complaint (b)(4) inside of the device.The advancer, handshake connections, coil, housing, sheath, burr, and annulus were visually and microscopically examined.Inspection of the device found that the body of the device was filled with excessive dried blood.The coil was found to be stretched.Functional testing was performed by attempting to remove the returned rotawire, and it was unable to be removed due to the stretched coil and excessive blood within the device.Further functional testing was performed by attempting to actuate the dynaglide mode change button, and the button was unable to be actuated.Testing of the saline infusion port found that fluid was not able to reach the end of the sheath and drip as intended due to the presence of excessive dried blood within the sheath.Testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to rotate.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.In order to determine the cause of the device stall, destructive testing was performed in which the advancer was dismantled and the interior components were examined.During inspection of the interior components, there were no damages identified, but excessive blood within the advancer body was noted.It is likely that the device stalled due to lack of lubricating material.During destructive testing, the dynaglide mode change button and board were examined.Examination found that the epoxy material had been applied incorrectly to the board, and prevented normal actuation of the dynaglide mode change button.Product analysis confirmed the reported inability of the dynaglide mode change button to actuate, as the placement of epoxy material on the board prevented the button from actuating.The reported speed not matching sound and unusual sound could not be confirmed, as the device stalled and would not run.The reported stuck rotawire was confirmed, as the rotawire received within the device was not able to be removed due to excessive dried blood and the stretched coil.The reported saline infusion blockage was able to be confirmed, as the presence of excessive dried blood within the sheath prevented the sheath from having a steady drip as intended.

Event Description

It was reported that the rotapro burr became stuck on the rotawire.A 1.50mm rotapro and a rotawire drive were selected to be used for procedure.The rotapro was prepped and platformed at 200,000rpm outside the patient.During procedure, the advancer dynaglide mode button did not respond unless it was pressed firmly and strongly.The rotation speed did not sound like 200,000rpm, the sound was a little closer to a low speed, even though, it was set to 200,000rpm.There was abnormal sound and the burr became stuck on the rotawire.Then, when the physician checked the flush lumen it was stopped as if it was clogged.There was resistance encountered during removal.The rotapro and the rotawire were removed together as one unit from the patient.The procedure completed successfully with another device.There were no patient complications and the patient was good post procedure.It was further reported that the 1.50mm rotapro and a rotawire drive did not encounter resistance during advancement.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12752629
• MDR Text Key: 280167324
• Report Number: 2134265-2021-13873
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

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: 06/18/2023
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0027518850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• 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