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

Model Number 29720

Device Problems Entrapment of Device (1212); Noise, Audible (3273); Intermittent Loss of Power (4016)

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

Event Date 07/05/2023

Event Type  Injury  

Event Description

It was reported that the burr stuck with the wire.The 50% stenosed target lesion was located in the moderately tortuous and 70% calcified tibial area.A 1.25mm peripheral rotalink plus and rotawire were selected for use.During the procedure, the device made an abnormal sound and it stopped.The burr was stuck and could not come out as a whole system with wire.The devices were pulled out using a non-bsc support catheter.It was reported the wire may have detached and the burr was stuck.The devices were removed completely from the patient and the procedure was completed using angioplasty.No complications were reported, and patient was fine post procedure.

Event Description

It was reported that the burr stuck with the wire.The 50% stenosed target lesion was located in the moderately tortuous and 70% calcified tibial area.A 1.25mm peripheral rotalink plus and rotawire were selected for use.During the procedure, the device made an abnormal sound and it stopped.The burr was stuck and could not come out as a whole system with wire.The devices were pulled out using a non-bsc support catheter.It was reported the wire may have detached and the burr was stuck.The devices were removed completely from the patient and the procedure was completed using angioplasty.No complications were reported, and patient was fine post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the peripheral rotalink device was connected to the rotablator console control system and the foot pedal was pressed while the returned rotawire was inserted, the device staled and would not run.Abnormal noises were heard coming from the device during attempted rotation.Further functional testing was performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted due to a kink in the proximal end of the wire.In order to determine the functionality of the peripheral rotalink device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the rotablator device with no resistance or issues.The peripheral rotalink device was then reconnected to the rotablator console control system.When the foot pedal was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.Product analysis confirmed the reported events, as the device stalled and generated abnormal noises during attempted rotation with the returned rotawire inserted but, was able to reach and maintain optimal rpm after the returned wire was removed with resistance.The returned wire was unable to be reinserted into the device due to a kink in the wire.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17405899
• MDR Text Key: 319878691
• Report Number: 2124215-2023-37270
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0031175595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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 Outcome(s): Required Intervention