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

Model Number 39467-125

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the burr became stuck on the rotawire.The 75% - 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).A 1.25mm rotapro and a rotawire were selected for procedure.The rotapro was prepped and platformed at 180,000rpm outside the patient, then advanced over the wire without resistance.A dynaglide mode was used when catheter was advanced to the lesion.During procedure, the burr rotation speed was at 180,000rpm.Then, there was degree of deceleration.During removal, the burr was stuck in the rotawire inside the patient.A resistance was encountered during removal.The rotapro and the rotawire were removed together as one unit from the patient.The procedure was completed with another rotapro and rotawire devices.There was no patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

• 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: 13090479
• MDR Text Key: 282910571
• Report Number: 2134265-2021-16126
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0027559759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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
• Patient Sex: Male