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

Model Number 2077-01

Device Problems Contamination (1120); Difficult to Advance (2920)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported that contamination of the device occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified artery.A 1.50mm rotapro and rotawire drive were selected for use.During preparation, the burr would not advance over the wire.Restriction was encountered on the wire, outside the guide catheter.The devices were exchanged for a new rotaburr and rotawire and the same issue occurred.Sterile blue fibers from sterile towels were noted to be wrapped around the wires.The procedure was completed successfully with a non-boston scientific device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: a photo was attached to the complaint showing the rotawire with a blue piece of fibrous foreign material on the wire.Returned product consisted of the rotawire drive and the rotapro used in the procedure.The proximal end, middle section, distal end, and spring tip were visually and microscopically examined.Inspection of the device found that blue fibrous foreign material was present on the rotawire in accordance with the reported events and attached photo.Functional testing was performed using the returned rotapro device.During testing, the returned rotawire was unable to be inserted through the returned rotapro device due to a kinked and stretched coil within the rotapro device.Product analysis confirmed the reported events.

Event Description

It was reported that contamination of the device occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified artery.A 1.50mm rotapro and rotawire drive were selected for use.During preparation, the burr would not advance over the wire.Restriction was encountered on the wire, outside the guide catheter.The devices were exchanged for a new rotaburr and rotawire and the same issue occurred.Sterile blue fibers from sterile towels were noted to be wrapped around the wires.The procedure was completed successfully with a non-boston scientific device.No patient complications were reported.

• Brand Name: ROTAWIRE DRIVE
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16690280
• MDR Text Key: 312797507
• Report Number: 2124215-2023-15520
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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 Expiration Date: 04/17/2024
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0029240032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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
• Treatment: GUIDE CATHETER: 7FR CLS3.5; GUIDE CATHETER: 7FR CLS3.5
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White