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

Model Number 2077-02

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

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that the burr was stuck on the wire.The target lesion was located in the non-tortuous and non-calcified artery.A 1.75mm rotapro and a rotawire drive were selected for use.During the procedure while advancing the guidewire to position in the lesion, resistance was noted in the distal part of the guide catheter, preventing movement forward.The whole system was removed, and it was found that the rotawire was stuck in the rotapro.The devices were removed with traction and the procedure was completed with a 1.5mm rotapro and a rotawire floppy.No patient complications reported.

Manufacturer Narrative

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

Manufacturer Narrative

E1.Initial reporter address (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual & microscope inspection showed that the spring tip was bent/kinked and stretched.

Event Description

It was reported that the burr was stuck on the wire.The target lesion was located in the non-tortuous and non-calcified artery.A 1.75mm rotapro and a rotawire drive were selected for use.During the procedure while advancing the guidewire to position in the lesion, resistance was noted in the distal part of the guide catheter, preventing movement forward.The whole system was removed, and it was found that the rotawire was stuck in the rotapro.The devices were removed with traction and the procedure was completed with a 1.5mm rotapro and a rotawire floppy.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: 17800412
• MDR Text Key: 324066290
• Report Number: 2124215-2023-51325
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0031784608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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
• Treatment: GUIDECATHETER-7FR EBU4; GUIDECATHETER-7FR EBU4
• Patient Sex: Male
• Patient Race: White