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

Model Number 2077-02

Device Problem Entrapment of Device (1212)

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

Event Date 12/10/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the burr was stuck on the wire.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotapro and a rotawire drive were selected for use.During insertion, the burr got stuck with the rotawire and was removed from the body together as one unit.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

A2.Age at time of event: (b)(6) years or older.Device evaluated by manufacturer: the device was returned for analysis.A rotawire drive within the returned rotapro device was returned for analysis.The proximal end, middle section, distal end, and spring tip were visually and microscopically examined.Inspection of the device found a kink at 37cm from the distal end of the rotawire.Functional testing was performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance, but was not able to be fully reinserted due to the kink in the rotawire.Product analysis confirmed the reported events, as the returned rotawire was able to be removed with resistance but was not able to be reinserted due to the kink in the rotawire.

Event Description

It was reported that the burr was stuck on the wire.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotapro and a rotawire drive were selected for use.During insertion, the burr got stuck with the rotawire and was removed from the body together as one unit.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: ROTAWIRE DRIVE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16048705
• MDR Text Key: 308014983
• Report Number: 2124215-2022-54739
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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 Expiration Date: 03/20/2024
• Device Model Number: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0029063752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/26/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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
• Patient Sex: Male