MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3560

Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that foreign material was present on the device.During preparation a substance was observed to adhere to the rotawire and wireclip torquer.The device was replaced and the procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter city: (b)(6).

Event Description

It was reported that a substance adhered on the device.A rotawire and wireclip torquer was selected for use.An unusuality was noted as there was a substance adhering on the rotawire.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the substance adhering on the rotawire appeared to be powder.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11373005
• MDR Text Key: 233300216
• Report Number: 2134265-2021-02181
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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: 03/18/2021
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0023508854
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1