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

Lot Number RP005903

Device Problem Unstable (1667)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 date of event: used (b)(6) 2023 as no event date was provided.

Event Description

It was reported that unstable speed occurred.A rotapro console was selected for use.During the procedure, an unusual fluctuation of the rotation speed in normal mode was observed.The set rotational speed was 180,000 but the speed range goes from 160,000 to 210,000.The procedure was completed with this device and no patient complications were reported.

Event Description

It was reported that unstable speed occurred.A rotapro console was selected for use.During the procedure, an unusual fluctuation of the rotation speed in normal mode was observed.The set rotational speed was 180,000 but the speed range goes from 160,000 to 210,000.The procedure was completed with this device and no patient complications were reported.

Manufacturer Narrative

B3 - date of event: used (b)(6) 2023 as no event date was provided.Device evaluated by mfr: the complaint device was received for product analysis.Console is at firmware version of v05.18.00 and passed final functional test with no issue.The "unusual fluctuation of the rotation speed" was not confirmed as stated by the complaint.Visual inspection failed due to a crooked bent/ knob.No other issues were identified during the product analysis.

• Brand Name: ROTAPRO
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16693548
• MDR Text Key: 312940691
• Report Number: 2124215-2023-15862
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056/S166
• 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: 08/04/2023

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 Lot Number: RP005903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1