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

Model Number 39467-150

Device Problems Device Damaged by Another Device (2915); Program or Algorithm Execution Failure (4036)

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

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that a guidewire fracture occurred, requiring additional intervention.A 1.50mm rotapro and rotawire were selected for use.During the procedure, dynaglide mode was unable to be used removing the rotapro burr.Therefore, the rotawire was removed while the rotapro was rotating, causing the wire to break.A piece of the wire was left in the coronary and eventually removed by a non-bsc snare.No further information is available.

Event Description

It was reported that a guidewire fracture occurred, requiring additional intervention.A 1.50mm rotapro and rotawire were selected for use.During the procedure, dynaglide mode was unable to be used removing the rotapro burr.Therefore, the rotawire was removed while the rotapro was rotating, causing the wire to break.A piece of the wire was left in the coronary and eventually removed by a non-bsc snare.No further information is available.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.Visual inspection of the device did not identify any damages or defects.Microscope inspection of the device found that the annulus was damaged.The damage to the annulus was considered consistent with interaction between the rotating burr and the rotawire.During wire insertion test, analysis was performed using a test rotawire and was not able to pass the damaged annulus.During functional test, when the advancer was connected to the console and the dynaglide mode change button was pressed, the console did not swap to dynaglide mode.Product analysis confirmed the reported events, as the annulus was damaged and prevented insertion of the rotawire, and pressing the dynaglide mode change button did not switch the console to dynaglide mode.

Manufacturer Narrative

H6 impact codes: corrected.Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.Visual inspection of the device did not identify any damages or defects.Microscope inspection of the device found that the annulus was damaged.The damage to the annulus was considered consistent with interaction between the rotating burr and the rotawire.During wire insertion test, analysis was performed using a test rotawire and was not able to pass the damaged annulus.During functional test, when the advancer was connected to the console and the dynaglide mode change button was pressed, the console did not swap to dynaglide mode.Product analysis confirmed the reported events, as the annulus was damaged and prevented insertion of the rotawire, and pressing the dynaglide mode change button did not switch the console to dynaglide mode.

Event Description

It was reported that a guidewire fracture occurred, requiring additional intervention.A 1.50mm rotapro and rotawire were selected for use.During the procedure, dynaglide mode was unable to be used removing the rotapro burr.Therefore, the rotawire was removed while the rotapro was rotating, causing the wire to break.A piece of the wire was left in the coronary and eventually removed by a non-bsc snare.No further information is available.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18711481
• MDR Text Key: 335472667
• Report Number: 2124215-2024-07624
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0032323060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/13/2024; 05/03/2024
• Supplement Dates FDA Received: 04/10/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• 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
• Patient Outcome(s): Required Intervention