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

Model Number	29720
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device separation occurred.The target lesion was located in the anterior tibial artery.A 2.00mm peripheral rotalink plus was selected for use.During the procedure, the rotablator stop working.Upon an attempt to remove the device, the tip got detached and left in the lesion.A snare was used to remove the fragment and expected the patient for a full recovery.The procedure was cancelled.No further patient complications were reported.
Event or Problem Description
It was reported that a device separation occurred.The target lesion was located in the anterior tibial artery.A 2.00mm peripheral rotalink plus was selected for use.During the procedure, the rotablator stop working.Upon an attempt to remove the device, the tip got detached and left in the lesion.A snare was used to remove the fragment and expected the patient for a full recovery.The procedure was cancelled.No further patient complications were reported.
Additional Manufacturer Narrative
H6 device code: corrected.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19795150
• Report Number: 2124215-2024-43804
• Device Sequence Number: 4134472
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 04/02/2026
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0033739765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 04/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown