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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was detached.The 100% stenosed target lesion was located in the non tortuous and heavily calcified left superficial femoral artery.A 1.50mm peripheral rotalink plus was selected for use.During procedure, it was noted that there was difficulty in manually advancing the burr to the peroneal.The device was activated via foot pedal and advanced with rotation.The device was deactivated upon reaching the intended location and then reactivated for ablation.The burr was attempted to be advanced using the knob.When the knob was retracted, the burr did not retract backwards with the catheter and the burr had become detached.The wire and rotalink system were removed together.The burr came out intact on the wire; however, it was detached from the tip of the catheter.Nothing remained behind in the patient.The procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual examination revealed that the burr was separated from the coil.The burr is missing.The coil is stretched, and the sheath is damaged at the distal end.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr was detached.The 100% stenosed target lesion was located in the non tortuous and heavily calcified left superficial femoral artery.A 1.50mm peripheral rotalink plus was selected for use.During procedure, it was noted that there was difficulty in manually advancing the burr to the peroneal.The device was activated via foot pedal and advanced with rotation.The device was deactivated upon reaching the intended location and then reactivated for ablation.The burr was attempted to be advanced using the knob.When the knob was retracted, the burr did not retract backwards with the catheter and the burr had become detached.The wire and rotalink system were removed together.The burr came out intact on the wire; however, it was detached from the tip of the catheter.Nothing remained behind in the patient.The procedure was completed with a different device.No patient complications were reported and 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
• MDR Report Key: 10505058
• Report Number: 2134265-2020-12344
• Device Sequence Number: 3033063
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/22/2020

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: 12/07/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023053145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR