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

Model Number	29720
Medical Device Problem Codes	Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device speed exceeds the set operational speed.Vascular access was obtained via dorsalis pedis using a 4f/5f non-boston scientific device.The target lesion was located at the right anterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During procedure, the burr was advanced into the mid calf and fist pass was attempted but the device stalled.Subsequently, the device was backed up using dynaglide approximately 2cm and tried again, and once again the device stalled in the same location.Another attempt was made but the same thing happened.At this point, the device was removed using dynaglide and proceeded to complete the procedure using balloon angioplasty only.However, it was further noted that the maximum speed the device reached was 202,000rpm which exceeds the set operational speed of 200,000rpm.There were no complications reported and the patient did well.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed no damages.Microscopic examination revealed damage to the annulus.Functional testing was performed by connecting it to a console and it would stall when tested.The device was disassembled and the ultem was melted while the turbine is corroded.Inspection of the remainder of the device presented no damage or irregularities.
Event or Problem Description
It was reported that the device speed exceeds the set operational speed.Vascular access was obtained via dorsalis pedis using a 4f/5f non-boston scientific device.The target lesion was located at the right anterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During procedure, the burr was advanced into the mid calf and fist pass was attempted but the device stalled.Subsequently, the device was backed up using dynaglide approximately 2cm and tried again, and once again the device stalled in the same location.Another attempt was made but the same thing happened.At this point, the device was removed using dynaglide and proceeded to complete the procedure using balloon angioplasty only.However, it was further noted that the maximum speed the device reached was 202,000rpm which exceeds the set operational speed of 200,000rpm.There were no complications reported and the patient did well.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10778349
• Report Number: 2134265-2020-15115
• Device Sequence Number: 19744225
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 09/01/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0025949273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1