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

Model Number	3320
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Returned product consisted of the atherectomy rotalink burr catheter.The handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection of the device revealed that the coil was kinked, stretched, and broken at the distal end of the coil.The burr was not returned for analysis.It was considered likely that the device was unable to cross the lesion due to this damage, or after this damage occurred.Product analysis confirmed the reported event, as the coil was kinked, stretched, and broken at the distal end of the coil.It was considered likely that the device was unable to cross the lesion due to this damage, or after this damage occurred.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 25apr2023.It was reported that the device could not cross the lesion.The 60mmx2.5mm, 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink burr was selected for use.During the procedure, it was noted that the device could not cross the lesion.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed that the device was broken at the distal end of the coil.

• 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 ; 6515811560
• MDR Report Key: 16815105
• Report Number: 2124215-2023-19770
• Device Sequence Number: 12143289
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 09/19/2023
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0028227103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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: Female
• Patient Weight: 67 KG