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

Model Number 39467-150

Device Problems Entrapment of Device (1212); Mechanical Problem (1384)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.A 1.50mm rotapro and a rotawire were selected for percutaneous coronary intervention (pci) procedure.The burr advanced to the lesion on dynaglide mode.The rotawire kept trying to jump forward while the burr was advancing, and the physician had a good hold on the distal end of the rotawire.After a quick single pass, the physician proceeded to remove the burr on dynaglide mode, however, the burr was stuck in the rotowire inside the patient during removal.The rotapro and the rotawire were pulled out and removed together as one unit from the patient.The procedure was completed successfully with another rotapro and rotawire devices.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: the rotapro atherectomy device was returned for analysis within the rotowire used in the procedure.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed with the returned rotowire.During functional testing, the returned rotowire was able to be removed with resistance but was not able to be reinserted into the rotapro device due to a kink in the rotowire.In order to determine the functionality of the rotapro device, a test rotowire was used.During analysis, the test rotowire was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.Further functional testing was performed by connecting the rotapro advancer to the rotapro console control system.When the knob switch [ablation button] was pressed, the brake activated and held the rotowire in place with no issues.No abnormal movement of the rotowire was identified during testing.Product analysis confirmed the reported stuck wire, as the returned rotowire was kinked and could not be reinserted into the returned rotapro device.The reported abnormal wire movement was not able to be confirmed, as the brake secured the rotowire during test rotation and no abnormal movement of the rotowire was identified.

Event Description

It was reported that device entrapment occurred.A 1.50mm rotapro and a rotawire were selected for percutaneous coronary intervention (pci) procedure.The burr advanced to the lesion on dynaglide mode.The rotawire kept trying to jump forward while the burr was advancing, and the physician had a good hold on the distal end of the rotawire.After a quick single pass, the physician proceeded to remove the burr on dynaglide mode, however, the burr was stuck in the rotowire inside the patient during removal.The rotapro and the rotawire were pulled out and removed together as one unit from the patient.The procedure was completed successfully with another rotapro and rotawire devices.There were no patient complications 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18750305
• MDR Text Key: 336189183
• Report Number: 2124215-2024-10394
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0032810425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• 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