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

Model Number 29720

Device Problems Device Contamination with Body Fluid (2317); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Event 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
• Type of Device: 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: 9780975
• MDR Text Key: 181830830
• Report Number: 2134265-2020-02430
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR