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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became detached and a snare catheter was used to retrieve the detached fragment.The 80% stenosed target lesion was located in the mildly tortuous and moderate to severely calcified left distal anterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During the procedure, the physician positioned the burr near the location of the target lesion, spun once and noticed that the burr broke off when trying to advance further down the anterior tibial artery for more treatment.A snare catheter was placed down the rotawire to retrieve the burr.After completely removing the burr, the physician just ballooned the artery.No further complications were reported and the patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the peripheral rotalink plus atherectomy device with a merit 3.2f snare catheter and a rotawire.The burr catheter was received attached to the advancer unit, but the coil was received detached from the burr catheter.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device revealed that the burr was detached from the coil and on the returned rotawire.The returned burr and rotawire were returned within the merit 3.2f snare catheter, but were able to be removed from the snare catheter without issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported event, as the burr was detached from the coil and on the returned rotawire.
Event or Problem Description
It was reported that the burr became detached and a snare catheter was used to retrieve the detached fragment.The 80% stenosed target lesion was located in the mildly tortuous and moderate to severely calcified left distal anterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During the procedure, the physician positioned the burr near the location of the target lesion, spun once and noticed that the burr broke off when trying to advance further down the anterior tibial artery for more treatment.A snare catheter was placed down the rotawire to retrieve the burr.After completely removing the burr, the physician just ballooned the artery.No further complications were reported and the patient fully recovered.

• 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: 11829596
• Report Number: 2134265-2021-06331
• Device Sequence Number: 17185391
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026631368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - ROTAWIRE; GUIDEWIRE - ROTAWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 66