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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was difficult to remove and was stuck on the rotawire.The target lesion was located in the mildly tortuous and mildly calcified tibial artery.A 1.25mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, it was noted that the burr was not easy to advance and retract.Consequently, the device was pulled out using dynaglide mode and made sure that the rotawire was not kinked and the rotaglide was dripping.The device was removed with the wire stuck in the catheter.The procedure was completed with a non boston scientific device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the burr was stuck within the sheath and was removed with resistance.It was noted that manipulation of the advancer knob was difficult while the burr remained stuck within the sheath.Functional testing was performed using the returned rotawire.During functional testing, the returned wire was able to be removed and reinserted through the device with no resistance or issues.Further functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the advancer was connected to the rotablator console control system and the foot pedal was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.Product analysis could not confirm the reported events, as the returned rotawire was able to be removed and reinserted with no resistance or issues and clinical circumstances were not able to be replicated.
Event or Problem Description
It was reported that the burr was difficult to remove and was stuck on the rotawire.The target lesion was located in the mildly tortuous and mildly calcified tibial artery.A 1.25mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, it was noted that the burr was not easy to advance and retract.Consequently, the device was pulled out using dynaglide mode and made sure that the rotawire was not kinked and the rotaglide was dripping.The device was removed with the wire stuck in the catheter.The procedure was completed with a non boston scientific device.No patient complications were 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13534298
• Report Number: 2134265-2022-01597
• Device Sequence Number: 5325016
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 04/30/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0027235153
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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 Sex: Unknown