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

Model Number	3280
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a labeling issue occurred.A rotalink advancer was selected for percutaneous coronary intervention.However, during the procedure, it was noted that the device did not match the label.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6) device evaluated by mfr: the complaint device was received for product analysis.The advancer body and handshake connection were visually examined.Inspection of the device presented no damage or irregularities.The batch number on the advancer was inspected and was found to be 30014220 in accordance with the reported batch number.Product analysis did not confirm the reported event, as there were no defects identified to the device, and the batch number on the device was found to match the batch number within the reported events.As additional packaging or other labeling content was not returned, the exact nature of the matching discrepancy was not able to be determined.
Event or Problem Description
It was reported that a labeling issue occurred.A rotalink advancer was selected for percutaneous coronary intervention.However, during the procedure, it was noted that the device did not match the label.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• 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: 17475040
• Report Number: 2124215-2023-40647
• Device Sequence Number: 15269000
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2024
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0030014220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG