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

Model Number 29720

Device Problems Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978); Noise, Audible (3273)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that the burr was stuck with the rotawire and foreign matter was noted on the burr.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 2.00mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, a pecking motion was used in advancing the burr; however, on the second pass, a constant bogging down noise on the advancer was heard and the burr was running very slow.Subsequently, the burr got stuck on the wire and could not be removed.When the device was pulled out altogether from the patient's body, they noticed a thin plastic that was wrapped around the burr and slightly around the shaft near the burr.The procedure was completed with a different device.No patient complications were reported.

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.As indicated in the reported events, the alleged plastic-like foreign material was not returned for analysis and was not able to be confirmed.There were no damages to the sheath that would indicate the identified material to be a separated portion of the sheath.Functional testing was initially 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 wire.In order to determine the functionality of the device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the device with no resistance or issues.Further functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the peripheral rotalink advancer was connected to the rotablator console control system and the foot pedal was pressed, the device stalled and would not run.In order to determine the cause of the device stall, functional testing was performed in which the advancer was dismantled and the interior components were inspected for damages or defects.Destructive testing was not able to identify the cause of the device stall.Product analysis confirmed the reported stuck wire, as the returned rotawire was able to be removed but was not able to be reinserted due to a kink in the wire body.The reported noise, rotation issues, and foreign material were not able to be confirmed, as the device stalled and the foreign material was not returned in accordance with the reported events.Destructive testing was not able to determine the cause of the device stall.

Event Description

It was reported that the burr was stuck with the rotawire and foreign matter was noted on the burr.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 2.00mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, a pecking motion was used in advancing the burr; however, on the second pass, a constant bogging down noise on the advancer was heard and the burr was running very slow.Subsequently, the burr got stuck on the wire and could not be removed.When the device was pulled out altogether from the patient's body, they noticed a thin plastic that was wrapped around the burr and slightly around the shaft near the burr.The procedure was completed with a different device.No patient complications were reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15300477
• MDR Text Key: 302260552
• Report Number: 2124215-2022-32565
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0028917917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 43 KG