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

Model Number 2077-01

Device Problem Difficult to Insert (1316)

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

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).

Event Description

It was reported that the procedure was cancelled.A rotawire drive was selected for use.During the procedure, it was noted that the device was unable to cross inside the guiding catheter and the procedure was not completed due to this event.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.It was found the body of the guidewire was bent, confirming the reported event.No further device issues were noted during evaluation.

Event Description

It was reported that the procedure was cancelled.A rotawire drive was selected for use.During the procedure, it was noted that the device was unable to cross inside the guiding catheter and the procedure was not completed due to this event.There were no patient complications 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17759171
• MDR Text Key: 323545807
• Report Number: 2124215-2023-47623
• 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: 10/30/2023

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: 0030668411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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