MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number	3320
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 26aug2022.It was reported that the handshake connection was kinked and burr could not cross.The 94% stenosed, 10mmx2.75mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the handshake connection was kinked and burr could not cross the guide catheter.The procedure was completed with a different device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that the sheath and coil were found to be cut at the proximal end.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a portion of the rotablator rotalink burr catheter.The guidezilla ii device used in the procedure was returned with the returned portion of the burr catheter inserted through the guidezilla ii device.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device found that blood was present within the sheath, on the sheath, and within the returned guidezilla ii device.The sheath and coil were found to be cut at the proximal end and 133cm of the burr catheter was found to be returned.Functional testing was performed by attempting to remove and reinsert the returned portion of the burr catheter.During functional testing, severe resistance was encountered during removal of the burr catheter due to the presence of blood within the guidezilla ii device and on the returned portion of the burr catheter.The device was unable to be reinserted due to the severe resistance.No other issues were identified during the product analysis.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15380947
• Report Number: 2124215-2022-34930
• Device Sequence Number: 5707361
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

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: 04/11/2023
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0027291674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 80 KG