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

Model Number H802228240020

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Elderly history of hypertension and congestive heart failure.When preparing for a transcatheter aortic valve replacement procedure, the rotawire was bent upon opening the package.The tip of the wore was disfigured and not used on the patient.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11494406
• MDR Text Key: 240080179
• Report Number: 11494406
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871(17)230105(10)26583947
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2021

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 Model Number: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 26583947
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Weight: 81