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

Model Number 39467-150

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

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

Event Date 01/08/2021

Event Type  malfunction  

Event Description

It was reported that there was foreign matter on the device.A 1.50mm rotapro was selected for an atherectomy procedure.Fibrous foreign matter was observed at the tip of the burr.The procedure was completed with a different 1.50mm rotapro.There were no patient complications reported.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of the rotapro atherectomy system.The burr catheter was received connected to the advancer unit.A photo of the device at the facility was also received.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that there was fibrous foreign matter (fm) on the tip that was most likely from the cloth/sheet used in the operating room during preparation or clothing.There was saline and blood on the coil and fm.It was also revealed that majority of the coil was stretched, indicating that there was tactile force applied to the coil.The photo was reviewed.It was found that the photo matches the returned device and the fm on the burr.

Event Description

It was reported that there was foreign matter on the device.A 1.50mm rotapro was selected for an atherectomy procedure.Fibrous foreign matter was observed at the tip of the burr.The procedure was completed with a different 1.50mm rotapro.There were no patient complications reported.It was further reported that the lesion being treated was the left anterior descending (lad) artery #6.The foreign matter attached to the burr after a distal gripper was removed from the burr.It is possible that the fibers were entangled from a water absorbing sheet in error during test rotation during preparation outside the patient.

Event Description

It was reported that there was foreign matter on the device.A 1.50mm rotapro was selected for an atherectomy procedure.Fibrous foreign matter was observed at the tip of the burr.The procedure was completed with a different 1.50mm rotapro.There were no patient complications reported.It was further reported that the lesion being treated was the left anterior descending (lad) artery #6.The foreign matter attached to the burr after a distal gripper was removed from the burr.It is possible that the fibers were entangled from a water absorbing sheet in error during test rotation during preparation outside the patient.

• 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: 11209146
• MDR Text Key: 228170303
• Report Number: 2134265-2021-00604
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: 03/19/2021

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: 09/25/2022
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0026079049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 02/04/2021; 02/26/2021
• Supplement Dates FDA Received: 02/17/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1