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

Model Number 39467-125

Device Problem Break (1069)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

It was reported that the drive shaft was broken.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.25mm rotapro was selected for use.After about 6 ablations with rota, it was presumed that the drive shaft was probably broken because the burr did not move when the knob was moved after the device's removal.The device was removed normally with dynaglide and the procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the handshake connection was not visible.In order to inspect the handshake connection, the burr housing was dismantled; it was found that the handshake connection was bent within the sheath and could not be retrieved from within the housing, contributing to the appearance of a broken drive shaft and preventing the movement of the burr using the advancer knob as the handshake connection was no longer connected.

Event Description

It was reported that the drive shaft was broken.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.25mm rotapro was selected for use.After about 6 ablations with rota, it was presumed that the drive shaft was probably broken because the burr did not move when the knob was moved after the device's removal.The device was removed normally with dynaglide and the procedure was completed with another of the same device.No patient complications reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16648855
• MDR Text Key: 312437245
• Report Number: 2124215-2023-13447
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0030734975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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
• Treatment: GUIDE CATHETER-HYPERION; GUIDE CATHETER-HYPERION; GUIDEWIRE-ROTAWIRE DRIVE; GUIDEWIRE-ROTAWIRE DRIVE; IMAGING CATHETER-OPTICROSS HD; IMAGING CATHETER-OPTICROSS HD