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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Physician was performing an atherectomy on the proximal left circumflex artery.The rotapro was being removed over the rotawire.The rotawire broke due to a heavily calcified lesion and was unable to be retrieved.A stent was placed successfully and there were no acute adverse events as a result.Fda safety report id# (b)(4).

• Brand Name: ROTAWIRE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752 1234
• MDR Report Key: 14756498
• MDR Text Key: 294575597
• Report Number: MW5110399
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/15/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White