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

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter got stuck in lesion.The lesion was located below the knee.A 2.00mm peripheral rotalink plus was selected for use.During procedure, it was noted that the catheter got stuck in lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patients status is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the coil was extremely stretched.The rotawire used in the procedure was returned, so it was used for functional testing.Functional testing was performed by attempting to advance the rotawire through the burr catheter and the advancer.The rotawire was not able to advance due to the extremely stretched coil.Functional testing was then performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.The rotablator advancer was then connected to the rotablator console.When the foot pedal was pressed, the advancer was able to reach and maintain optimal rpm with no issues.
Event or Problem Description
It was reported that the catheter got stuck in lesion.A 2.00mm peripheral rotalink plus was selected for use.During procedure, it was noted that the catheter got stuck in lesion.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11844793
• Report Number: 2134265-2021-06410
• Device Sequence Number: 3425165
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 02/05/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026758936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR