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

Model Number	29720
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood leaked from the rotaburr sheath.The multiple tight stenosed target lesion was located in the moderately tortuous and approximately 250mm in length of extremely heavy calcified superficial femoral and popliteal artery.A 2.00mm peripheral rotalink plus was selected for use.During procedure, after transversing about 100mm of the heavily calcified superficial femoral artery, it was noticed that the device stopped functioning correctly and blood was leaking out of the device.The rotalink plus was removed over the rotawire from inside the patient with no issues other than the device was leaking with blood/saline.This was after use of about 2-3 minutes in the patient.It was thought that the rotalink was punctured by a sharp calcification.The procedure was completed with another of the same device.No patient complications were reported and patient was good post procedure.

• 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: 9780975
• Report Number: 2134265-2020-02430
• Device Sequence Number: 2788123
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 03/03/2020

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: 09/23/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024484929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR