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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was stuck on the wire, and it came off and remain inside the patient.A 2.50mm rotalink plus along with a peripheral rotawire were selected for use.During the procedure, it was noted that the rotalink plus became stuck on the rotawire.While attempting to remove the device the radiopaque tip of the peripheral rotawire came off and remained inside the popliteal artery.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection of the device did not reveal any damages or defects.Functional testing was performed using the returned rotawire.The returned rotawire was able to be removed with resistance and was not able to be reinserted due to a kink in the proximal end of the wire.During testing with the returned rotawire, in order to determine the functionality of the peripheral rotalink device, a test rotawire was used.The test rotawire was able to be fully inserted and removed with no resistance or issues.Product analysis confirmed the reported event, as there was resistance encountered during removal due to a kink in the proximal end of the returned rotawire.The returned rotawire was not able to be reinserted due to the kink.
Event or Problem Description
It was reported that the device was stuck on the wire, and it came off and remain inside the patient.A 2.50mm rotalink plus along with a peripheral rotawire were selected for use.During the procedure, it was noted that the rotalink plus became stuck on the rotawire.While attempting to remove the device the radiopaque tip of the peripheral rotawire came off and remained inside the popliteal artery.The procedure was cancelled.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: 13895809
• Report Number: 2134265-2022-03401
• Device Sequence Number: 4470587
• Product Code: MCW
• UDI-Device Identifier: 08714729838968
• UDI-Public: 08714729838968
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 11/19/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0028418776
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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 Age: 73 YR
• Patient Sex: Female