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

Lot Number 21202449

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2019

Event Type  Injury  

Event Description

A rotawire was introduced and advanced into the left circumflex artery.A 1.5 burr was introduced and advanced into left circumflex and the vessel treated with rotational coronary atherectomy at 190,000 rmps.The tip of the rotawire broke off and was in one of the small branches of left circumflex.No contrast was noted to extravasate around the area where the tip was located.Fda safety report id # (b)(4).

• Brand Name: ROTAWIRE
• Type of Device: CATHETER, CORONARY ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8640469
• MDR Text Key: 146237675
• Report Number: MW5086877
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/21/2019

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 Lot Number: 21202449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR
• Patient Weight: 94