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

Model Number	3280
Medical Device Problem Codes	Gas/Air Leak (2946); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A rotalink advancer was selected for use.Prior to procedure, physician informed that advancer was leaking.When speed was tested console showed stall and procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) 2024 as no event date was reported.E1 - initial reporter address 1: (b)(6).

• Brand Name: ROTALINK ADVANCER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19367176
• Report Number: 2124215-2024-30310
• Device Sequence Number: 17767261
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2025
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0032225908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown