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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that burr detachment occurred.A 1.50mm peripheral rotalink plus was selected for use.During preparation, it was noted that there was no burr attached to the catheter tip.It is unknown if the burr was already detached upon removal from the packaging or detached during testing of the device.There was no damage noticed on the original packaging.The procedure was completed using an additional rotalink plus.No patient complications reported.
Event or Problem Description
It was reported that burr detachment occurred.A 1.50mm peripheral rotalink plus was selected for use.During preparation, it was noted that there was no burr attached to the catheter tip.It is unknown if the burr was already detached upon removal from the packaging or detached during testing of the device.There was no damage noticed on the original packaging.The procedure was completed using an additional rotalink plus.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the peripheral rotalink plus atherectomy device.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil was stretched and broken at the point of detachment confirming the reported event.A photo provided showed the stretched and broken coil in accordance with findings during analysis.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16542027
• Report Number: 2124215-2023-10395
• Device Sequence Number: 15070822
• 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
• Report Date (Section B): 04/13/2023

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: 11/29/2024
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0030624427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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