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	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the wire.A 2.00mm peripheral rotalink plus and a peripheral rotawire guidewire were selected for use.During the procedure, it was noted that the burr became stuck with the wire.The device was removed through dynaglide mode and the procedure was completed with the original device.No complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the burr became stuck with the wire.A 2.00mm peripheral rotalink plus and a peripheral rotawire guidewire were selected for use.During the procedure, it was noted that the burr became stuck with the wire.The device was removed through dynaglide mode and the procedure was completed with the original device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the peripheral rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The rotawire used in the procedure was returned through complaint (b)(4) and was received within the device.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was initially performed using the returned rotawire.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 proximal end of the wire.In order to determine the functionality of the peripheral rotalink plus device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the device with no resistance or issues.Product analysis confirmed the reported event, as the returned rotawire was able to be removed with resistance but was not able to be reinserted due to a kink in the proximal end of the wire.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14707732
• Report Number: 2134265-2022-06926
• Device Sequence Number: 2135846
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 11/03/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0028320933
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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: GENERATOR - JETSTREAM; GENERATOR - JETSTREAM
• Patient Age: 69 YR
• Patient Sex: Male