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

Model Number 39467-125

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

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that there was foreign material on the burr tip.A 1.25mm rotapro was selected for use in an atherectomy procedure.The 95% stenosed target lesion was severely calcified and located in mildly tortuous anatomy.A rotawire was inserted into the advancer and crossed the lesion.Rotation speed was tested outside the body.A fiber-like material was observed to be wrapped around the diamond burr.The rotapro was exchanged for another of the same.At this time, the rotawire was noted to be deformed so it was also exchanged for another of the same.The procedure was completed without further issue.No patient complications were reported.The physician commented that the burr may have come into contact with the surgical drape when rotation speed was adjusted.

Event Description

It was reported that there was foreign material on the burr tip.A 1.25mm rotapro was selected for use in an atherectomy procedure.The 95% stenosed target lesion was severely calcified and located in mildly tortuous anatomy.A rotawire was inserted into the advancer and crossed the lesion.Rotation speed was tested outside the body.A fiber-like material was observed to be wrapped around the diamond burr.The rotapro was exchanged for another of the same.At this time, the rotawire was noted to be deformed so it was also exchanged for another of the same.The procedure was completed without further issue.No patient complications were reported.The physician commented that the burr may have come into contact with the surgical drape when rotation speed was adjusted.It was further reported that the rotawire deformation was a bend in the mid-part of the wire.The condition of the patient post procedure was good.

Manufacturer Narrative

E1: initial reporter address 1 - (b)(6).E1: initial reporter city - (b)(6).

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11385866
• MDR Text Key: 233778826
• Report Number: 2134265-2021-02459
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: 04/05/2021

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: 09/01/2022
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0025949276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/14/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR