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

Model Number	3320
Medical Device Problem Codes	Connection Problem (2900); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that the device could not be connected and would stall.The 38mm x 3.0mm in diameter, 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink burr was selected for use.During the procedure, it was noted that the tail of the burr and the tip of the advancer could not be closely connected and would stall.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable after the procedure.However, device analysis revealed that the coil and sheath detached on the proximal end.Also, the sheath was torn.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.E1 - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device identified that the sheath and coil were detached on the proximal end, and the total returned length of the sheath was 140.3cm, and the coil was 143.8cm (which includes the burr).The proximal end of the returned coil was stretched for a length of 17.2cm.The most proximal end of the returned sheath was stretched for 8cm.The handshake connection, burr housing and the proximal end of the sheath failed to return for further analysis.Microscope inspection of the device found no further damage or irregularity.Media depicts a portion of the burr catheter with coil and sheath detachment on the proximal end.The coil is visibly stretched.The damage present confirms the reported connection issue due to detachments present.

• 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 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: 21048434
• Report Number: 2124215-2024-80199
• Device Sequence Number: 8409276
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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): 12/31/2024

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: 01/29/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0033316659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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
• Patient Sex: Male