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

Model Number	3280
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the wire.The target lesion was located in the left anterior descending artery (lad).A rotalink advancer w/tubular drive shaft and rotawire were selected for rotational atherectomy.During preparation, the guidewire was wound together with the burr.The procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the burr became stuck with the wire.The target lesion was located in the left anterior descending artery (lad).A rotalink advancer w/tubular drive shaft and rotawire were selected for rotational atherectomy.During preparation, the guidewire was wound together with the burr.The procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital e1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual examination of the device found that the handshake connection was bent, and the advancer knob was not returned for further analysis.Wire insertion test revealed that the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and removed from the device with no resistance or issues.

• 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 CORK LIMITED; 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: 19851080
• Report Number: 2124215-2024-46400
• Device Sequence Number: 15055277
• 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): 10/02/2024

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: 12/11/2024
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0030830049
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 88 KG