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

Model Number	29720
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotawire was broken.The target lesion was located in the anterior tibial artery.A rotawire and wireclip torquer (bx5) and a 1.50mm peripheral rotalink plus was selected for use.During the procedure, when the foot pedal was stepped on and began to advance the burr, it was making an abnormal sound.The device was stop and pulled back the rotawire a bit but the end of the wire was not coming back.The physician assumed the wire was broken approximately 20-30 cm from distal end.They removed the proximal portion of the rotawire while the distal portion remain visible beyond the rota device in the tibial.When the rotalink plus was removed, the distal wire came with it.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the rotawire was broken.The target lesion was located in the anterior tibial artery.A rotawire and wireclip torquer (bx5) and a 1.50mm peripheral rotalink plus was selected for use.During the procedure, when the foot pedal was stepped on and began to advance the burr, it was making an abnormal sound.The device was stop and pulled back the rotawire a bit but the end of the wire was not coming back.The physician assumed the wire was broken approximately 20-30 cm from distal end.They removed the proximal portion of the rotawire while the distal portion remain visible beyond the rota device in the tibial.When the rotalink plus was removed, the distal wire came with it.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
D4: lot number corrected from 0027904058 to 0027904055.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 found that the handshake connection had separated.Functional testing was initially performed using a test rotawire as the rotawire used during the procedure was not returned for analysis.During testing, the rotawire was able to be inserted and advanced pass the burr annulus, but was not able to pass the damaged handshake connection.In order to confirm the reported noise issues, the returned advancer was rotated on its own with the separated portion of the burr catheter handshake connection attached.During rotation, it was noted that the separated portion of the burr catheter handshake connection made contact with the interior walls of the advancer and generated an abnormal noise.In order to confirm the functionality of the advancer, further functional testing was performed using a test burr catheter with the returned advancer.During functional testing, the advancer was connected to the rotablator console controls system.When 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 fractured rotawire, as the rotawire was not returned for analysis and clinical circumstances were unable to be replicated.The reported abnormal noises were able to be confirmed, as the separated portion of the handshake connection made contact within the interior walls of the advancer and generated an abnormal noise during test rotation.
Event or Problem Description
It was reported that the rotawire was broken.The target lesion was located in the anterior tibial artery.A rotawire and wireclip torquer (bx5) and a 1.50mm peripheral rotalink plus was selected for use.During the procedure, when the foot pedal was stepped on and began to advance the burr, it was making an abnormal sound.The device was stop and pulled back the rotawire a bit but the end of the wire was not coming back.The physician assumed the wire was broken approximately 20-30 cm from distal end.They removed the proximal portion of the rotawire while the distal portion remain visible beyond the rota device in the tibial.When the rotalink plus was removed, the distal wire came with it.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
D4: lot number corrected from 0027904058 to 0027904055.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15066503
• Report Number: 2124215-2022-26426
• Device Sequence Number: 5699123
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/25/2022

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: 08/25/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0027904055
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 08/01/2022; 08/22/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/17/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown