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

Model Number 3243

Device Problems Entrapment of Device (1212); Output Problem (3005); Intermittent Loss of Power (4016)

Patient Problem Cardiac Arrest (1762)

Event Date 02/07/2024

Event Type  Death  

Event Description

It was reported that the patient died.The 90-95% stenosed target lesion was located in the moderately tortuous and severely calcified proximal to mid circumflex artery.A 1.25mm rotapro was selected for use.During the procedure, the burr advanced through the non-boston scientific (bsc)guide catheter, then the burr advanced around the tortuous circumflex on dynaglide mode.The burr advanced into the lesion and passed the entry point.The ablation started in the middle of the lesion and not at the proximal lesion.It was noticed that the burr rotation speed was at 130,00rpm rather than the set operation speed of 165,000rpm in the mid lesion.The burr pulled back, then the burr advanced to the lesion again but, the burr was not spinning up to the set rotation speed so, the physician decided to stop and remove the burr.During withdraw the device, the burr stuck in the lesion, and the device stalled in dynaglide mode.As the physician tried to pull the burr, the non-bsc guide catheter kept advancing into the left main artery up to the bifurcation.The patient was recommended to cough or try nitro but, the patient started to decompensate and was not responding at that point.The burr remained stuck in the nodular calcium when the patient begun to arrest.While the medical team was attending to the patient, the physician pulled the burr and successfully removed it intact.Then, an imaging catheter advanced to lesion, and it was noted that the guide caused a major dissection to the left main artery.The patient still had flow, and there was no dissection in the circumflex artery.The medical team continued resuscitating the patient and had a paced rhythm and pressure after 45 minutes.The physicians stated that the patient was too sick and would not make it through another surgery.The patient was then transferred to the intensive care unit.The patient died in that evening after the procedure.The official cause of death was dissection to left main.

• 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: 18811115
• MDR Text Key: 336591599
• Report Number: 2124215-2024-09128
• 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
• Report Date: 02/29/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/29/2024
• 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
• Treatment: 3.5 EBU GUIDE CATHETER - MEDTRONIC
• Patient Outcome(s): Death; Required Intervention
• Patient Sex: Female