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

Model Number 3243

Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the burr was contaminated.A 1.25mm rotapro burr was selected for use.However, it was noted that the device was defective and contaminated.No complications were reported.

Manufacturer Narrative

Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.

Manufacturer Narrative

B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by mfr.: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that foreign material resembling dried saline and blood was present on the coil near the burr.In order to determine the nature of the material, ftir testing was performed, and the material was found to most closely resemble saline and blood.

Event Description

It was reported that the burr was contaminated.A 1.25mm rotapro burr was selected for use.However, it was noted that the device was defective and contaminated.No complications were reported.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16403684
• MDR Text Key: 309877491
• Report Number: 2124215-2023-07257
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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 Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0030469731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• 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