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

Model Number 29720

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Event Description

It was reported that the burr was stuck in the lesion.The 100% stenosed target lesion was located in the moderate to severely calcified distal post tibial artery.A 1.50mm peripheral rotalink plus was selected for use.During the procedure, the device entered the target lesion and stalled out.It would not start spinning again and would not advance forward or backward with use of the advancer knob.It was noted that the burr was stuck in the lesion.The physician pulled the entire catheter back and the device was freed and was able to spin again outside the patient's body.Physician did not re-deliver the device as the stenosis was too tight and calcified.It was then treated by percutaneous transluminal angioplasty and the procedure was completed without performing rotablation.No complications were reported and the patient was fine 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: 11359197
• MDR Text Key: 233051080
• Report Number: 2134265-2021-02131
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026079033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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