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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Noise, Audible (3273); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).Initial reporter state: (b)(6).
Event or Problem Description
It is reported that a rotapro and rotawire entrapment occurred.A percutaneous coronary intervention (pci) procedure was being performed.The target lesion was location in the 90% stenosed, mildly tortuous, and severely calcified mid left anterior descending artery.Rotablation was performed with a 1.75mm burr along with a rotawire they decided to size up to a 2.15mm rotapro.There was no resistance encountered during advancement to the lesion before ablation.During removal while in dynaglide mode the burr was unable to move, the console stall light was displayed and a high pitched sound heard.The device was able to be forcefully removed as a unit.Once the device was outside the patient they attempted to remove the device but it was severe and difficult to remove.The procedure had been completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.E1: initial reporter state: (b)(6).The returned product consisted of the rotapro atherectomy system with the related rotawire and mach1 guide catheter.The burr catheter was received attached to the advancer unit with the rotawire inside the rotapro device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the rotapro device.The rotawire was received inside the rotapro device and was able to be moved distally out of the burr catheter with no resistance or issues.The burr catheter was then advanced through the returned mach1 guide catheter.It was found that the burr catheter could be inserted through the guide catheter with resistance due to damages to the guide catheter.Functional testing was performed in order to confirm the reported unusual noises.During functional testing, the rotapro advancer was connected to the rotapro control console.When the knob switch was pressed, the device stalled and would not run.Destructive testing was performed to identify the cause of the device stall, but destructive testing was not conclusive.There is not enough evidence to definitively say what the reason for the device stall was.Product analysis did not confirm the reported event, as the rotawire was able to be removed from the rotapro device with no resistance or issues.The reported noise issues were not able to be confirmed, as the device stalled and would not run.
Event or Problem Description
It is reported that a rotapro and rotawire entrapment occurred.A percutaneous coronary intervention (pci) procedure was being performed.The target lesion was location in the 90% stenosed, mildly tortuous, and severely calcified mid left anterior descending artery.Rotablation was performed with a 1.75mm burr along with a rotawire they decided to size up to a 2.15mm rotapro.There was no resistance encountered during advancement to the lesion before ablation.During removal while in dynaglide mode the burr was unable to move, the console stall light was displayed and a high pitched sound heard.The device was able to be forcefully removed as a unit.Once the device was outside the patient they attempted to remove the device but it was severe and difficult to remove.The procedure had been 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: 11995485
• Report Number: 2134265-2021-07663
• Device Sequence Number: 922870
• Product Code: MCX
• UDI-Device Identifier: 08714729893394
• UDI-Public: 08714729893394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 07/24/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025764406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/01/2021
• Patient Sequence Number: 1