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

Model Number 39467-200

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported that a hole in the catheter occurred.The chronic totally occluded (cto) target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 2.00mm rotapro was selected for use.During preparation, the rota burr was opened, and the wire was loaded, then the draw test was performed.The saline infused with rotaglide leaked from the shaft side at the proximal part of the burr.The procedure was completed with a new burr.No complications were 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: 17830576
• MDR Text Key: 324445687
• Report Number: 2124215-2023-52794
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/27/2023

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: 39467-200
• Device Catalogue Number: 39467-200
• Device Lot Number: 0029722108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Male