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

Model Number	3280
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that fluid leak occurred.The target lesion was located in the left circumflex artery.A rotalink advancer w/tubular drive shaft was selected for use.During the procedure, it was noted that the device was leaking air and water and was unusable.The procedure was completed with another of the same device.No patient complications and the patient was stable after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device revealed no damages or defects.Functional testing was initially performed by connecting the returned advancer to the liquid infusion line.When liquid was advanced through the device, a light drip at the advancer body was noted as intended by design.There were no abnormal fluid leaks identified during functional testing.Further functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to be rotated with no issue.Then functional testing was performed by connecting the advancer to the rotablator control console system.When the foot pedal was pressed, the advancer stalled and would not run.The sound of air escaping the device could be heard during the device stall.In order to determine the cause for the stall, destructive testing was performed, in which the advancer was dismantled and the interior components were inspected for damages or defects.Destructive testing was unable to identify the cause of the stall.Product analysis did not confirm the reported fluid leak, as there were no abnormal leaks identified during functional testing.The sound of air escaping the device could be heard during the device stall.Destructive testing was unable to determine the cause of the device stall, and clinical circumstances were unable to be replicated.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that fluid leak occurred.The target lesion was located in the left circumflex artery.A rotalink advancer w/tubular drive shaft was selected for use.During the procedure, it was noted that the device was leaking air and water and was unusable.The procedure was completed with another of the same device.No patient complications and the patient was stable after the procedure.

• Brand Name: ROTALINK ADVANCER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16225485
• Report Number: 2124215-2023-01964
• Device Sequence Number: 12074604
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 05/07/2024
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0029539860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 65 KG