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

Model Number 39467-150

Device Problems Break (1069); Noise, Audible (3273)

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

Event Date 04/29/2021

Event Type  malfunction  

Event Description

It was reported that a shaft fracture occurred.The 85% stenosed target lesion was located in the severely calcified ostial left anterior descending artery (lad).A 1.50mm rotapro was advanced in the guide catheter.The rotapro was turned on for the first run when a noise was heard and the middle of the drive shaft was noted to be fractured.The hemostatic valve could have potentially made contact with the device at the site of fracture.All pieces of the rotapro were removed together as one from the patient.The procedure was completed with another of the same rotapro and a new guidewire.There were no patient complications.

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that a shaft fracture occurred.The 85% stenosed target lesion was located in the severely calcified ostial left anterior descending artery (lad).A 1.50mm rotapro was advanced in the guide catheter.The rotapro was turned on for the first run when a noise was heard and the middle of the drive shaft was noted to be fractured.The hemostatic valve could have potentially made contact with the device at the site of fracture.All pieces of the rotapro were removed together as one from the patient.The procedure was completed with another of the same rotapro and a new guidewire.There were no patient complications.It was further reported that the rotapro fractured while on the rotawire.There were no issues observed with the rotawire.The rotawire was pulled to remove the entire device.The patient's status was healthy post procedure.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the sheath was torn at 21.5mm from the distal end of the strain relief.The damage is consistent to the damage caused by over-tightening the hemostasis valve.In order to confirm the reported abnormal noises, the device was functional tested.Functional testing was performed by connecting the rotapro advancer to the rotapro console control system.When the knob (ablation switch) was pressed, the device did not get any speed and stalled.Destructive testing was performed to determine the cause of the device stall, but testing was not able to determine the cause of the stall.Product analysis confirmed the reported damage to the sheath, but the reported unusual noises could not be performed due to the device stalling.Destructive testing was not able to determine the cause of the device stall.

Event Description

It was reported that a shaft fracture occurred.The 85% stenosed target lesion was located in the severely calcified ostial left anterior descending artery (lad).A 1.50mm rotapro was advanced in the guide catheter.The rotapro was turned on for the first run when a noise was heard and the middle of the drive shaft was noted to be fractured.The hemostatic valve could have potentially made contact with the device at the site of fracture.All pieces of the rotapro were removed together as one from the patient.The procedure was completed with another of the same rotapro and a new guidewire.There were no patient complications.It was further reported that the rotapro fractured while on the rotawire.There were no issues observed with the rotawire.The rotawire was pulled to remove the entire device.The patient's status was healthy post procedure.

• 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: 11845821
• MDR Text Key: 251411730
• Report Number: 2134265-2021-06414
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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: 01/27/2023
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0026707741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 05/19/2021; 06/29/2021
• Supplement Dates FDA Received: 06/08/2021; 07/08/2021
• Patient Sequence Number: 1