MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. CATHETER, CORONARY, ATHERECTOMY; ROTAWIRE, FLOPPY

Catalog Number H802228240022

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2020

Event Type  malfunction  

Event Description

While preforming a rotational atherectomy procedure to the proximal lad, the distal end of the wire unraveled and was retained in a distal septal branch of the lad; interventional radiology (scime).Fda safety report id # (b)(4).

• Brand Name: CATHETER, CORONARY, ATHERECTOMY
• Type of Device: ROTAWIRE, FLOPPY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 10372942
• MDR Text Key: 202065267
• Report Number: MW5095910
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: H802228240022
• Device Lot Number: 24182296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 89 YR
• Patient Weight: 93