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

Model Number 39467-150

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Cardiac Arrest (1762)

Event Date 03/08/2024

Event Type  Death  

Event Description

It was reported that the burr became stuck in the lesion and the patient died.The stenosed target lesion was located in the severely calcified left main artery.During the procedure, the drip line was running when platformed outside the body.The sound heard was not as expected, but the burr was platforming at 170,000 rpms and so the procedure was continued with the burr.Once the lesion was approached, dynaglide was turned off, and prepared to ablate the lesion, however the speed rapidly declined and the burr became stuck in the lesion.Attempt was made to dislodge the burr, but it couldn't be removed.As dislodgment was attempted, the patient coded.After cpr and stabilizing the patient, the burr was successfully removed.The patient left the cath lab stable, however passed away during the night.Further information is not available.

• 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: 19042000
• MDR Text Key: 339383664
• Report Number: 2124215-2024-19318
• 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
• Report Date: 04/04/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0032838574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• 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): Death