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

Model Number 39467-150

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

It was reported that blood flowed back into the drive shaft sheath.A 1.50mm rotapro was selected for use.During the procedure, it was noted that blood flowed back into the drive shaft sheath when ablation started, even though the saline was flowing normally.The infusion fluid was also flowing at a prescribed pressure, and when it was taken out of the body, the backflowing blood was also pushed out by the infusion fluid.The device was removed from the patient's body using normal removal and the procedure was completed using this device.There was no patient injury.

Event Description

It was reported that blood flowed back into the drive shaft sheath.A 1.50mm rotapro was selected for use.During the procedure, it was noted that blood flowed back into the drive shaft sheath when ablation started, even though the saline was flowing normally.The infusion fluid was also flowing at a prescribed pressure, and when it was taken out of the body, the backflowing blood was also pushed out by the infusion fluid.The device was removed from the patient's body using normal removal and the procedure was completed using this device.There was no patient injury.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.No blood was identified within the device in accordance with the reported events.Functional testing was performed by connecting the device to the liquid infusion line.During liquid infusion, there were no leaks noted and a steady drip of fluid was seen from the distal end of the sheath as intended by design.Product analysis could not confirm the reported events, as there was no blood present within the device in accordance with the reported events, and the clinical circumstances were unable to be replicated.No other issues were identified during the product analysis.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16097069
• MDR Text Key: 308269924
• Report Number: 2124215-2022-55894
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

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: 02/22/2024
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0028920757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1