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

Model Number 3280

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

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

Event Date 12/15/2022

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 308591032
• Report Number: 2124215-2023-01964
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 65 KG