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 Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.
Event or Problem Description
It was reported that the rotalink burr tip broke.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that the rotalink burr tip broke and was retrieved from the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to(b)(6)2020 as no event date was reported.
Event or Problem Description
It was reported that the rotalink burr tip broke.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that the rotalink burr tip broke and was retrieved from the patient's body.No patient complications were reported.It was further reported that the device was used in the lower extremities and was successfully removed from the patient's body using a snare.Furthermore, proper closure device was used on patient and patient was discharged as per facility protocol.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9799955
• Report Number: 2134265-2020-02696
• Device Sequence Number: 19536852
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023859775
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention