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

Model Number 39467-150

Device Problem Mechanical Problem (1384)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was report that the brake did not work effectively during ablation.The target lesion was located in the distal left anterior descending artery (lad).A 1.50mm rotapro was selected for percutaneous coronary intervention (pci) procedure.The rotowire was fed down to distal lad and the burr was loaded and advanced into the mid lad without issue.However, the wire was started to pull back after one pass.Then, the physician stopped to re-feed wire.After two or three passes, the wire was still coming back when the physician attempted to treat the calcium.The wire was held manually to maintain wire position during the remainder of the procedure.The procedure was completed successfully with this device.The burr and wire were removed from the patient without any problem.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 SCIMED, INC; 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: 18382578
• MDR Text Key: 331190229
• Report Number: 2124215-2023-71952
• 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
• Report Date: 12/22/2023

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: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0032012928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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 Sex: Male