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

Model Number 3560

Device Problems Entrapment of Device (1212); Defective Device (2588); Difficult to Advance (2920)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

It was reported that the burr got stuck on wire.A rotawire guidewire was selected for use and was dressed with a wet compress upon unpacking.The rotawire guidewire and rotapro device were used together during the procedure.During pullback of the devices, it was difficult to track the rotapro burr on the guidewire and the wire appeared blunt.The rotawire was removed manually and in dynaglide mode.The rotawire guidewire was removed intact and the procedure was able to be completed with the same rotapro device.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter telephone: (b)(6).Device evaluated by manufacturer: the rotawire: ic device was returned for investigation.Visual and microscopic investigation confirmed the spring tip was observed to be bent and stretched.

Event Description

It was reported that the burr got stuck on wire.A rotawire guidewire was selected for use and was dressed with a wet compress upon unpacking.The rotawire guidewire and rotapro device were used together during the procedure.During pullback of the devices, it was difficult to track the rotapro burr on the guidewire and the wire appeared blunt.The rotawire was removed manually and in dynaglide mode.The rotawire guidewire was removed intact and the procedure was able to be completed with the same rotapro device.No patient complications were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17475400
• MDR Text Key: 320632501
• Report Number: 2124215-2023-41879
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0030922012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1