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

Model Number 3243

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

Patient Problems Ischemia (1942); Myocardial Infarction (1969); No Code Available (3191)

Event Date 07/06/2020

Event Type  Injury  

Event Description

It was reported that the device became stuck inside the anatomy, and the patient experienced myocardial infarction and ischemia.A 1.75mm rotapro catheter was selected for an atherectomy procedure in the left anterior descending (lad) coronary artery to treat coronary artery disease.The lesion was heavily calcified with minimal tortuosity.The device stalled once while platforming outside the body, but the procedure continued with the same device.Inside the patient, the speed was set to 160k rpm when the device experienced a sudden drop in speed.The device stalled inside the lad and became stuck in the anatomy.The advancer was disconnected, and the device was twisted counterclockwise.Eventually, the device was removed before surgery was needed.The patient experienced a myocardial infarction and ischemia.Extracorporeal membrane oxygenation (ecmo) was performed.The patient was admitted to the hospital beyond standard of care.The patient is expected to fully recover.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10344904
• MDR Text Key: 201076783
• Report Number: 2134265-2020-10170
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2020

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: 07/10/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention