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

Model Number	H80222782001A0
Medical Device Problem Codes	Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a brake malfunction occurred.The 85% stenosed target lesion was located in the severely tortuous and calcified left anterior descending artery.A rotalink advancer and rotawire were selected for use.During the procedure, the guidewire was damaged and ejected causing the advancer to be scrapped.The procedure was completed using another of the same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that a brake malfunction occurred.The 85% stenosed target lesion was located in the severely tortuous and calcified left anterior descending artery.A rotalink advancer and rotawire were selected for use.During the procedure, the guidewire was damaged and ejected causing the advancer to be scrapped.The procedure was completed using another of the same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older e1 - initial reporter facility name:(b)(6) hospital.E1 - initial reporter address 1: (b)(6).D4 - lot #: corrected device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the handshake connection was bent.During wire insertion test, as the rotawire used in the procedure was not returned, a test rotawire was used for further testing.After inserting the test rotawire into the returned advancer without issue or resistance, further testing was completed.During functional analysis, the brake defeat button was pushed and was able to engage and disengage with the wire without issue or resistance.No other issues were identified during the product analysis.

• Brand Name: ROTALINK ADVANCER
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21019932
• Report Number: 2124215-2024-80786
• Device Sequence Number: 14445272
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• 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,Followup
• Report Date (Section B): 02/20/2025

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: 03/01/2026
• Device Model Number: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0033539845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: Unknown