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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - over 18 years old.
Event or Problem Description
It was reported that the rotapro became stuck to the rotawire.The target lesion was located in the mildly tortuous left anterior descending artery (lad).A rotapro 1.75mm and rotawire were selected for use.The devices were advanced to the lesion.Rotational speed was set to 180,000 rpm.Atherectomy was performed.Stall occurred when removing the rotapro in dynaglide mode.It was noted that the rotapro became stuck to the rotawire during removal.The procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned device consisted of the rotapro atherectomy system.Visual and microscope inspection revealed that the device presented no damage or irregularities.The rotawire was able to be inserted into the burr and advanced through the advancer with no resistance or issues.Functional testing was performed by connecting the rotapro advancer to the rotapro console control system.When the knob switch [ablation button] was pressed, the device was able to reach and maintain optimal speed with no resistance or issues.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the rotapro became stuck to the rotawire.The target lesion was located in the mildly tortuous left anterior descending artery (lad).A rotapro 1.75mm and rotawire were selected for use.The devices were advanced to the lesion.Rotational speed was set to 180,000 rpm.Atherectomy was performed.Stall occurred when removing the rotapro in dynaglide mode.It was noted that the rotapro became stuck to the rotawire during removal.The procedure was completed with this device.No patient complications were reported.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12215396
• Report Number: 2134265-2021-09468
• Device Sequence Number: 14528439
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026060286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1