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

Model Number	29720
Medical Device Problem Codes	Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically 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 rotate.Then functional testing was performed by connecting the advancer to the rotablator control console system.When the foot pedal was pushed, the advancer was not able to run, so it didn't get any speed and a stall error was displayed on the console.In order to determine the cause of the device stall, destructive testing was performed, in which the advancer was dismantled, the components inside the advancer were inspected, and there were no damages or irregularities identified.The cause could not be confirmed.
Event or Problem Description
It was reported that the device exceeded the set operational speed.The target lesion was located in the right anterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During the procedure, the device was making unexpected noises when the pedal was depressed to run the device.Additionally, the device did not appear to be moving as expected inside the vessel on the fluoroscopy.Subsequently, the set operational speed was 176,000 rpm however, the maximum speed reached was at 182,000 rpm.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: 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: 15429412
• Report Number: 2124215-2022-35070
• Device Sequence Number: 7502216
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0029395431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female