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

Model Number	3320
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 15mmx3.0mm, stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotalink burr and rotawire were selected for use.During the procedure, it was noted that the rotawire was intertwined with the burr.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed with the returned rotawire.During functional testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted into the rotapro device due to a kink in the rotawire.In order to determine the functionality of the rotapro device, a test rotawire was used.During analysis, the test rotawire was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.
Event or Problem Description
It was reported that device entrapment occurred.The 15mmx3.0mm, stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotalink burr and rotawire were selected for use.During the procedure, it was noted that the rotawire was intertwined with the burr.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17119434
• Report Number: 2124215-2023-28021
• Device Sequence Number: 12522267
• 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,Followup
• Report Date (Section B): 07/10/2023

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: 01/10/2024
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0028834732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 81 KG