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

Model Number 39467-125

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Intermittent Loss of Power (4016)

Patient Problems Hematoma (1884); Vascular Dissection (3160)

Event Date 07/24/2023

Event Type  Injury  

Event Description

It was reported that the burr became stuck in the lesion.A rotapro 1.25mm was selected for use during a coronary intervention procedure.The target lesion was located in the mid left anterior descending artery (lad) and was 90% stenosed and moderately tortuous.During the procedure, it was noted that the burr had stalled due to becoming stuck in the lesion.The physician attempted to pull on the device to free it, however this was not successful.A second access to the target lesion was gained, where a wire and balloon were advanced to assist in freeing the rotapro 1.25mm burr from the lesion.The balloon was inflated, and the burr was successfully removed from the target lesion, however the patient experienced hematoma and a dissection.The procedure was completed using another similar device, and the patient is expected to fully recover.

Manufacturer Narrative

Device evaluation by mfr: the returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch/ablation button was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.Product analysis confirmed the reported stall, as the device stalled and was not able to run due to blood within the device.The reported difficulty encountered during removal and burr becoming stuck within the sheath were not able to be confirmed as clinical circumstances were unable to be replicated.

Event Description

It was reported that the burr became stuck in the lesion.A rotapro 1.25mm was selected for use during a coronary intervention procedure.The target lesion was located in the mid left anterior descending artery (lad) and was 90% stenosed and moderately tortuous.During the procedure, it was noted that the burr had stalled due to becoming stuck in the lesion.The physician attempted to pull on the device to free it, however this was not successful.A second access to the target lesion was gained, where a wire and balloon were advanced to assist in freeing the rotapro 1.25mm burr from the lesion.The balloon was inflated, and the burr was successfully removed from the target lesion, however the patient experienced hematoma and a dissection.The procedure was completed using another similar device, and the patient is expected to fully recover.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17558354
• MDR Text Key: 321269172
• Report Number: 2124215-2023-43907
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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 Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0031516170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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
• Patient Outcome(s): Required Intervention