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

Lot Number RP005898

Device Problem Output Problem (3005)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3 date of event: date of event was approximated to 04/01/2023 as no event date was reported.

Event Description

It was reported that rotation speed was abnormal.A rotapro console kit assy japan zero was selected for use.During the procedure, the rotation speed was abnormal.The situation did not change despite checking the connection, turning the power off and on, and replacing the advancer.No complications were reported.

Manufacturer Narrative

B3 date of event: date of event was approximated to 04/01/2023 as no event date was reported.Device evaluated by mfr.: the device was returned for analysis.The console failed the final functional test relating to the dynaglide.The device did not meet specification for offset-normal mode minimum flow rate.The allegation of abnormal rotational speeds was confirmed.The console passed the visual inspection with no signs of damage.

Event Description

It was reported that rotation speed was abnormal.A rotapro console kit assy japan zero was selected for use.During the procedure, the rotation speed was abnormal.The situation did not change despite checking the connection, turning the power off and on, and replacing the advancer.No complications were reported.

• 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): EP TECHNOLOGIES, INC.; 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: 19184896
• MDR Text Key: 341117905
• Report Number: 2124215-2024-24211
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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: Other
• Device Lot Number: RP005898
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1