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

Model Number 3243

Device Problem Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Event Description

It was reported that the rotapro became stuck on the rotawire.A 1.25mm rotapro and rotawire were selected for an atherectomy procedure.During the procedure, the rotawire became stuck inside the rotapro when performing dynaglide.Another 1.25mm rotapro and rotawire were used to complete the procedure.There were no patient complications reported and the procedure was fine.

Event Description

It was reported that the rotapro became stuck on the rotawire.A 1.25mm rotapro and rotawire were selected for an atherectomy procedure.During the procedure, the rotawire became stuck inside the rotapro when performing dynaglide.Another 1.25mm rotapro and rotawire were used to complete the procedure.There were no patient complications reported and the procedure was fine.It was further reported that the target lesion was located inside the left anterior descending artery.The rotawire became stuck inside the rotapro while advancing the rotapro system through the guide catheter.

Manufacturer Narrative

Device technical analysis: the returned complaint device consisted of a rotapro unit with a guidewire from complaint 13179965 inside the device.The handshake connection and drive shaft were microscopically and visually examined.Visual and microscopic examination revealed no damages.A device to device interaction test was performed by inserting a test guidewire into the device and it was able to pass through.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage that could have contributed to the reported event.

Event Description

It was reported that the rotapro became stuck on the rotawire.A 1.25mm rotapro and rotawire were selected for an atherectomy procedure.During the procedure, the rotawire became stuck inside the rotapro when performing dynaglide.Another 1.25mm rotapro and rotawire were used to complete the procedure.There were no patient complications reported and the procedure was fine.It was further reported that the target lesion was located inside the left anterior descending artery.The rotawire became stuck inside the rotapro while advancing the rotapro system through the guide catheter.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11117848
• MDR Text Key: 225124129
• Report Number: 2134265-2020-18765
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

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: 03/02/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025290751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/13/2021; 02/19/2021
• Supplement Dates FDA Received: 01/21/2021; 02/26/2021
• Patient Sequence Number: 1