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

Model Number 2077-01

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that the rotawire was detached.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.A 2.00mm rotapro and a rotawire were selected for use.During the procedure, the physician tried to advance the burr to the lesion using dynaglide and it was noted that the rotawire that was advanced to the coronary artery was being pulled back.Furthermore, the rotawire was separated.The burr was removed outside the body together with the rotawire system.The procedure was completed with another of the same device.There was no patient injury reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The proximal end and wire body were visually and microscopically examined.Inspection of the device found that the wire was kinked at 15cm from the distal tip.No fractures of the wire were noted.

Event Description

It was reported that the rotawire was detached.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.A 2.00mm rotapro and a rotawire were selected for use.During the procedure, the physician tried to advance the burr to the lesion using dynaglide and it was noted that the rotawire that was advanced to the coronary artery was being pulled back.Furthermore, the rotawire was separated.The burr was removed outside the body together with the rotawire system.The procedure was completed with another of the same device.There was no patient injury 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: rache shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17745569
• MDR Text Key: 323402196
• Report Number: 2124215-2023-37950
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

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: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0031065610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2023
• 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