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

Model Number	3241
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.Vascular access was obtained via right femoral artery.The 24mm x 4.00-4.80mm, 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 330 cm rotawire and wireclip torquer and a 1.75 mm rotalink plus were selected for use.During the procedure, a non-boston scientific 7fr guide catheter with a non-boston scientific guidewire were used to cannulate the calcified right coronary artery but could not advance distally, so a non-boston scientific microcatheter was used to provide better support.Then, a rotawire guidewire was advanced through the microcatheter and the 1.75 mm rotalink plus was delivered to ablate the mid-right coronary artery.After ablation was carried out successfully for three runs, the rotalink plus was removed from the microcatheter.As the rotalink plus was removed via dynaglide mode, it was noted that the rotawire was kinked, the stalled option appeared, and the rota system (rotalink plus and rotawire) were stuck together and could not be removed pneumatically.The whole system was manually removed and the procedure completed with another of same device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
The device was returned for evaluation.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Prior to removal of the rotawire, functional testing was performed by connecting the rotablator advancer to the rotablator console control system.When the foot pedal was pressed and the returned rotawire was inserted, the device stalled and would not run.During testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted due to a kink in the rotawire.After removal of the returned rotawire, the rotablator advancer was connected to the rotablator console control system.When the foot pedal was pressed and the rotawire was removed, the device was able to reach and maintain optimal rpm with no resistance or issues.Additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the rotablator device with no resistance or issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.Vascular access was obtained via right femoral artery.The 24mm x 4.00-4.80mm, 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 330 cm rotawire and wireclip torquer and a 1.75 mm rotalink plus were selected for use.During the procedure, a non-boston scientific 7fr guide catheter with a non-boston scientific guidewire were used to cannulate the calcified right coronary artery but could not advance distally, so a non-boston scientific microcatheter was used to provide better support.Then, a rotawire guidewire was advanced through the microcatheter and the 1.75 mm rotalink plus was delivered to ablate the mid-right coronary artery.After ablation was carried out successfully for three runs, the rotalink plus was removed from the microcatheter.As the rotalink plus was removed via dynaglide mode, it was noted that the rotawire was kinked, the stalled option appeared, and the rota system (rotalink plus and rotawire) were stuck together and could not be removed pneumatically.The whole system was manually removed and the procedure completed with another of same device.No complications were reported and the patient was stable post procedure.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14950350
• Report Number: 2134265-2022-07670
• Device Sequence Number: 6945388
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 11/16/2022

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: 09/01/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0028124606
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: MEDTRONIC JR 3.5 7 FR; GUIDE CATHETER: MEDTRONIC JR 3.5 7 FR; MICROCATHETER: TERUMO FINECROSS; MICROCATHETER: TERUMO FINECROSS
• Patient Age: 54 YR
• Patient Sex: Male