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

Lot Number RP001030

Device Problems Unstable (1667); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that speed increased during the procedure.A rotapro console was selected for an atherectomy procedure.The speed was set to 180,000 rotations per minute (rpm).Rotation speed during ablation at the lesion increased.There were no patient complications reported.

Event Description

It was reported that speed increased during the procedure.A rotapro console was selected for an atherectomy procedure.The speed was set to 180,000 rotations per minute (rpm).Rotation speed during ablation at the lesion increased.There were no patient complications reported.It was further reported that the target lesion was moderately calcified and located in mildly tortuous anatomy within the left anterior descending artery.The device exceeded the set speed with a maximum rotation speed of 190,000 rpm.The procedure was completed with this device.

Event Description

It was reported that speed increased during the procedure.A rotapro console was selected for an atherectomy procedure.The speed was set to 180,000 rotations per minute (rpm).Rotation speed during ablation at the lesion increased.There were no patient complications reported.It was further reported that the target lesion was moderately calcified and located in mildly tortuous anatomy within the left anterior descending artery.The device exceeded the set speed with a maximum rotation speed of 190,000 rpm.The procedure was completed with this device.

Manufacturer Narrative

Device eval by mfr: the console was returned in over all good physical condition.The console failed incoming functional testing.The console failed intermittently.It failed to activate turbine flow in normal mode when the knob button on the advancer simulator was pressed.Console also failed due to poor electrical contact between the male connector of the advance simulator and the female electrical connector on the console.This triggers the shutoff of the air supply to the console during testing.The air supply is shut down whenever the advancer simulator connector or cable is touched.This points to a defective electrical connector.However, the reported jumping in speed was not duplicated.The front housing assembly which contains the electrical connector was replaced.That resolved the intermittent issues.The rotapro passed calibration and full functional final testing.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11012783
• MDR Text Key: 221808547
• Report Number: 2134265-2020-17822
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

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 Lot Number: RP001030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/22/2020; 03/18/2021
• Supplement Dates FDA Received: 01/07/2021; 04/12/2021
• Patient Sequence Number: 1