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

Model Number 3243

Device Problems Defective Device (2588); Device Contamination with Chemical or Other Material (2944); Intermittent Loss of Power (4016)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported that there was a foreign material contamination.A 1.25mm rotapro was noted to have a foreign material contamination during the procedure.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Correction: b5 event description updated to add description of device not functioning.Correction: h6 device code added.Device evaluated by manufacturer: returned product consisted of the rotapro advancer.The burr catheter was not returned for analysis.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that blood was present within the device.No forms of non-procedural matter were identified within the returned device that would suggest contamination.In order to determine the functionality of the returned device, the drive shaft was attempted to be rotated and was unable to rotate.When the rotapro advancer was connected to the rotapro console control system and the knob switch (ablation button) was pressed, the device stalled and would not run due to the presence of blood within the device.Product analysis did not confirm the reported contamination, as there were no non-procedural materials identified within the device that would suggest device contamination prior to usage within the procedure.The reported functionality issues were able to be confirmed, as the device stalled and would not run due to the presence of blood within the device.

Event Description

It was reported that foreign material contamination occurred.A 1.25mm rotapro was noted to not function and to have foreign material contamination during the procedure.The procedure was completed with another 1.25mm rotapro.No patient complications were reported.

Event Description

It was reported that a device stall occurred.A 1.25mm rotapro was noted to stall during the procedure.The procedure was completed with another 1.25mm rotapro.No patient complications were reported.Additional information: there was no foreign material contamination noted as was originally reported.

Manufacturer Narrative

Correction to b5 - update to incident description.Rewritten completely, as reported event changed via information provided by good faith efforts.Correction to h6 - correction coding, as reported event changed via information provided by good faith efforts.Based on the additional information received from the healthcare facility and results of the device analysis, this event no longer meets the criteria for a reportable event.It was originally reported that foreign material contamination occurred, however it was confirmed that the reported event was for a device stall, which does not meet the requirements for a reportable complaint.Stalling is a function to prevent patient injury.If the device is in a stall state, it is not operable and there is no risk to the patient and is unlikely to cause or contribute to a death or serious injury.Alternative therapies are available.Device evaluated by manufacturer: returned product consisted of the rotapro advancer.The burr catheter was not returned for analysis.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that blood was present within the device.No forms of non-procedural matter were identified within the returned device that would suggest contamination.In order to determine the functionality of the returned device, the drive shaft was attempted to be rotated and was unable to rotate.When the rotapro advancer was connected to the rotapro console control system and the knob switch (ablation button) was pressed, the device stalled and would not run due to the presence of blood within the device.Product analysis did not confirm the reported contamination, as there were no non-procedural materials identified within the device that would suggest device contamination prior to usage within the procedure.The reported functionality issues were able to be confirmed, as the device stalled and would not run due to the presence of blood within the device.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17337814
• MDR Text Key: 319217017
• Report Number: 2124215-2023-37641
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

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: 0030366477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/03/2023; 09/21/2023
• Supplement Dates FDA Received: 09/01/2023; 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1