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

Model Number 3243

Device Problems Break (1069); Failure to Advance (2524); Intermittent Loss of Power (4016)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

It was reported that a detachment occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified osital obtuse marginal artery.A 1.25mm rotapro was selected for use.During the procedure, it was attempted to advance the burr numerous times but with no success.A 7f non-boston scientific guide was used for extra support.After applying force into the lesion, the device stalled.The device was removed in dynaglide mode quickly.However, upon attempted removal, the driveshaft broke from the tip of the burr.The detached burr was pulled over the wire and removed.The procedure was completed, and no patient complications were reported.

Event Description

It was reported that a detachment occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified osital obtuse marginal artery.A 1.25mm rotapro was selected for use.During the procedure, it was attempted to advance the burr numerous times but with no success.A 7f non-boston scientific guide was used for extra support.After applying force into the lesion, the device stalled.The device was removed in dynaglide mode quickly.However, upon attempted removal, the driveshaft broke from the tip of the burr.The detached burr was pulled over the wire and removed.The procedure was completed, and no patient complications were reported.It was further reported that the set operational and maximum speed reached is 150,000 rpm.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15890028
• MDR Text Key: 305800886
• Report Number: 2124215-2022-49412
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 12/26/2022

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 Expiration Date: 04/23/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0029276338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2022
• 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: GUIDECATHETER-7F GUIDELINER; GUIDECATHETER-7F GUIDELINER