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

Model Number 39467-150

Device Problems Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that the burr was stuck on wire and a foreign object was present on the draft shaft.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal right coronary artery.A 1.50mm rotapro and rotawire drive were selected for use.During the procedure, upon insertion, the burr got stuck on the wire.The device was pulled out separately without rotating.Consecutively, after device removal, it was found out that a foreign material was present in the drive shaft.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that the burr was stuck on wire and a foreign object was present on the draft shaft.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal right coronary artery.A 1.50mm rotapro and rotawire drive were selected for use.During the procedure, upon insertion, the burr got stuck on the wire.The device was pulled out separately without rotating.Consecutively, after device removal, it was found out that a foreign material was present in the drive shaft.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found material present on the distal end of the coil and burr.During testing, the wire was able to be inserted and removed with no resistance or issues.Analysis of the material present on the burr did not identify any non-procedural materials.It was considered likely that the material identified on the coil had accumulated due to procedural factors.A photo was attached to the complaint record showing the material present on the burr and coil in accordance with findings during analysis.

• 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: 19015683
• MDR Text Key: 339092136
• Report Number: 2124215-2024-17657
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 0033049346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2023
• 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