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)

Patient Problem Extravasation (1842)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device revealed no damages or defects.As the wire used in the procedure was returned within the device, testing was performed using the returned wire.The returned rotawire was able to be removed and reinserted with resistance due to kinks in the returned wire.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to be rotated with no issue.Then functional testing was performed by connecting the peripheral rotalink plus advancer to the rotablator console control system.The advancer was able to reach and maintain optimal speed with no issues or noises.

Event Description

It was reported that the burr was stuck on wire.The target lesion was located in a non-tortuous and moderately calcified tibial artery.A 1.25mm peripheral rotalink plus and rotawire was selected for use.During the procedure, advancement was fine, but when the device entered the dense plaque, the advancer made a loud grinding noise so the physician stopped.The device was removed but it got stuck on the wire and would not come off.The burr and the wire were pulled out together and intact using dynaglide mode.A contrast run was performed afterwards and an extravasation of the vessel was found.It was uncertain if it was the burr or that the patients vessel was so diseased that actually caused the extravasation.It was noted that it might have been the plaque and the burr got trapped and couldn't spin and got hung up on the wire.A sterling balloon catheter was used to complete the procedure.There were no complications 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13447929
• MDR Text Key: 285046696
• Report Number: 2134265-2022-00844
• 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
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026673721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• 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