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

Model Number 3243

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 07/25/2022

Event Type  Injury  

Event Description

It was reported that the burr became stuck in the lesion and detached.A percutaneous coronary intervention was being performed on a severely calcified and tortuous lesion using a rotapro 1.50mm for treatment.During the procedure the rotapro burr became stuck in the lesion.When attempting to free the burr from the lesion, the physician noticed that the burr had become detached from the rest of the device.The detached burr however, was still connected to the guidewire.In order to remove the detached burr from the patient, the physician used an angioplasty kit to perform rescue angioplasty.They dissected the coronary artery and aorta and were able to perform a ping pong procedure to remove the burr.The burr was successfully removed from the patient after 5 hours, and the patient fully recovered.

Event Description

It was reported that the burr became stuck in the lesion and detached.A percutaneous coronary intervention was being performed on a severely calcified and tortuous lesion using a rotapro 1.50mm for treatment.During the procedure the rotapro burr became stuck in the lesion.When attempting to free the burr from the lesion, the physician noticed that the burr had become detached from the rest of the device.The detached burr however, was still connected to the guidewire.In order to remove the detached burr from the patient, the physician used an angioplasty kit to perform rescue angioplasty.They dissected the coronary artery and aorta and were able to perform a ping pong procedure to remove the burr.A hematoma was noted in the aorta following the angioplasty.The burr was successfully removed from the patient after 5 hours, and the patient fully recovered.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The device was received with the burr separated.The burr was received on the returned rotawire.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil had been kinked, stretched, and broken at the point of detachment from the burr.Product analysis confirmed the reported event, as the burr was received detached from the coil, and the coil was kinked, stretched, and broken at the point of detachment.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15269656
• MDR Text Key: 298375552
• Report Number: 2124215-2022-31748
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0029082617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention