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

Model Number 39467-125

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2023

Event Type  Injury  

Event Description

It was reported that the patient had an open-heart surgery to remove the burr.The target lesion as in the right coronary artery.A 1.25mm rotapro and a rotawire were selected for use.During the procedure, the rota burr would not advance onto the rotawire, was getting stuck and would not come out the end.Hence, the burr got stuck in the coronary artery and the patient had to undergo an open-heart surgery to remove the stuck burr.The patient was admitted to hospital beyond standard of care but was eventually discharged.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.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 with the returned rotawire.During functional testing, the returned rotawire was able to be removed with resistance, but was not able to be reinserted into the rotapro device due to a kink in the rotawire.In order to determine the functionality of the rotapro device, a test rotawire was used.During analysis, the test rotawire was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.Further 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 reached and maintained optimal rpm with no resistance or issues.Product analysis confirmed the reported stuck wire, as the returned rotawire was kinked and could not be reinserted into the returned rotapro device.The reported device becoming stuck within the lesion was not able to be confirmed, as clinical circumstances were not able to be replicated, and the device was able to reach and maintain optimal rpm during analysis.

Event Description

It was reported that the patient had an open-heart surgery to remove the burr.The target lesion as in the right coronary artery.A 1.25mm rotapro and a rotawire were selected for use.During the procedure, the rota burr would not advance onto the rotawire, was getting stuck and would not come out the end.Hence, the burr got stuck in the coronary artery and the patient had to undergo an open-heart surgery to remove the stuck burr.The patient was admitted to hospital beyond standard of care but was eventually discharged.

• 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 SCIMED, INC; 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: 17424845
• MDR Text Key: 320112363
• Report Number: 2124215-2023-37417
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: 11/20/2023

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: 0030639038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Male