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

Model Number 39467-150

Device Problems Break (1069); Entrapment of Device (1212); Output Problem (3005)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Myocardial Infarction (1969)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the burr became stuck in the lesion, ischemia, and myocardial infarction occurred.The target lesion was located in the mildly tortuous and severely calcified circumflex artery.This 1.50mm rotapro was selected for use atherectomy procedure.The rotapro was prepped and platformed at 160,000rpm outside the patient, then advanced over the wire.During procedure, the rotation speed dropped to 103,000rpm and the device stalled.Then, the burr became stuck in the lesion.The physician cut the drive shaft from distal to the nose cone.The physician attempted "mother-in-daughter" technique, a chest compressions dislodged the burr from the calcium and the device removed from the patient.The patient became hypotensive, myocardial infarction and ischemia occurred.A cardiopulmonary resuscitation (cpr) was performed, and a non-boston scientific heart pump device was placed.No further complications reported and the patient was stable post procedure.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12696443
• MDR Text Key: 278334822
• Report Number: 2134265-2021-13401
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: 10/26/2021

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 Expiration Date: 05/14/2023
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0027315777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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: IMPELLA HEART PUMP - ABIOMED
• Patient Outcome(s): Required Intervention