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

Model Number 3243

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/04/2021

Event Type  malfunction  

Event Description

It was reported that there was foreign material on the burr tip.A 1.75mm rotapro was selected for use in an atherectomy procedure.During loading of the rotapro onto the guidewire, debris was observed on the tip of the burr.The burr never entered the patient's body.The rotapro was removed and exchanged for another of the same.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of the rotapro atherectomy system.The burr catheter was received detached from the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.The burr was inspected, and no debris was identified on the tip or body of the burr.

Event Description

It was reported that there was foreign material on the burr tip.A 1.75mm rotapro was selected for use in an atherectomy procedure.During loading of the rotapro onto the guidewire, debris was observed on the tip of the burr.The burr never entered the patient's body.The rotapro was removed and exchanged for another of the same.No patient complications were reported.

• 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: 11844772
• MDR Text Key: 251408963
• Report Number: 2134265-2021-06451
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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: 03/19/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0027001417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/20/2021
• Patient Sequence Number: 1