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

Model Number 39467-150

Device Problems Break (1069); Entrapment of Device (1212); Intermittent Loss of Power (4016)

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

Event Date 12/22/2022

Event Type  malfunction  

Event Description

It was reported that the burr became stuck in the lesion.The target lesion was located in the severely calcified proximal left anterior descending artery.A 1.50mm rotapro was selected for use.During procedure, it was noted that the rotation speed suddenly increased during ablation, and then the stall has turned on.The burr stopped rotating and it was confirmed that it got stuck.The burr was removed by cutting the drive shaft and was retrieved using a guide extension catheter.The device was completely removed from the patient's body and the procedure was completed with the device.The physician thought that the drive shaft might have been separated that caused the rotation to stop and the burr to get stuck.There was no patient injury.

Event Description

It was reported that the burr became stuck in the lesion.The target lesion was located in the severely calcified proximal left anterior descending artery.A 1.50mm rotapro was selected for use.During procedure, it was noted that the rotation speed suddenly increased during ablation, and then the stall has turned on.The burr stopped rotating and it was confirmed that it got stuck.The burr was removed by cutting the drive shaft and was retrieved using a guide extension catheter.The device was completely removed from the patient's body and the procedure was completed with the device.The physician thought that the drive shaft might have been separated that caused the rotation to stop and the burr to get stuck.There was no patient injury reported.

Manufacturer Narrative

Device evaluated by mfr: 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 coil was stretched and broken and that the sheath was separated near the burr housing strain relief in accordance with the reported events indicating that the device was cut.There were no other detachments or separations identified.Due to the damage to the coil and sheath, further functional testing of the burr catheter was not able to be performed.Further functional testing of the advancer was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.A test burr catheter was connected to the advancer and used for analysis.When the rotapro advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the advancer was able to reach and maintain optimal rpm using a test burr catheter.Product analysis confirmed the reported separation, as the sheath and coil were separated as indicated in the reported events.The reported stall and device becoming stuck in the lesion were unable to be confirmed as the advancer was able to reach and maintain optimal rpm with a test burr catheter, and clinical circumstances were unable to be replicated.No other issues were identified during the product analysis.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16190283
• MDR Text Key: 308107084
• Report Number: 2124215-2022-56602
• 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: 03/24/2023

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 Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0030457570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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