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

Device Problem Entrapment of Device (1212)

Patient Problem Cardiogenic Shock (2262)

Event Date 03/31/2023

Event Type  Death  

Event Description

It was reported that the patient died.A rotapro was selected for pre transcatheter aortic valve implantation (tavi) procedure.During the procedure, the burr became stuck in the lesion after the first ablation due to the calcification and tortuosity.A several attempts were made to remove the burr using several techniques: buddy wire and a small balloon on the burr placed, used an extension guide wire with dynaglide mode, but it was unsuccessful.After several maneuvers to remove the burr, the patient died.As per physician's opinion, the patient was so weak and unstable with a very highly calcified and tortuous ductus arteriosus (da), the device or procedure did not cause or contribute to the patient complication as the patient's death was caused by cardiogenic shock.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16771217
• MDR Text Key: 313600449
• Report Number: 2124215-2023-18691
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P900056
• 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
• Report Date: 04/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Death