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

Model Number	3241
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported guidewire entrapment occurred.A 1.75mm rotalink plus and rotawire and wireclip torquer were selected for a coronary angiography and interventricular angioplasty procedure with active stent placement.During the beginning of the procedure, the guidewire became blocked and was unable to pass through the rotalink plus.The guidewire rotates when the motor is turned on.No patient complications were reported.
Event or Problem Description
It was reported guidewire entrapment occurred.A 1.75mm rotalink plus and rotawire and wireclip torquer were selected for a coronary angiography and interventricular angioplasty procedure with active stent placement.During the beginning of the procedure, the guidewire became blocked and was unable to pass through the rotalink plus.The guidewire rotates when the motor is turned on.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the rotalink rotablator plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.Functional testing was performed with a test rotawire, as the rotawire used in the procedure was not returned for analysis.The test wire was able to be advanced through the rotablator device and removed without resistance or issues.Functional testing was then performed by connecting the rotablator advancer to the rotablator console control system.When the foot pedal was pressed, the brake activated and was not able to rotate or be adjusted while the foot pedal was pressed.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12233154
• Report Number: 2134265-2021-09634
• Device Sequence Number: 14393066
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 01/06/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026758948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: 70 YR
• Patient Sex: Unknown