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

Model Number 2077-01

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that a foreign object was present on the device.A rotawire drive was selected for use.During the procedure, it was noted that a foreign object was found on the device.The procedure was completed with another rotawire drive.There were no patient complications reported.

Event Description

It was reported that a foreign object was present on the device.A rotawire drive was selected for use.During the procedure, it was noted that a foreign object was found on the device.The procedure was completed with another rotawire drive.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the rotawire drive was returned for analysis.During device investigation, no foreign material was present on the device.Therefore, the reported event was not confirmed.The spring tip was observed to be bent.

• Brand Name: ROTAWIRE DRIVE
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17760903
• MDR Text Key: 323591065
• Report Number: 2124215-2023-48173
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0031065614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2023
• 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