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

Model Number 29720

Device Problems Output Problem (3005); Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10778349
• MDR Text Key: 214350173
• Report Number: 2134265-2020-15115
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (y/n): N
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1