MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -16; WIRE, GUIDE, CATHETER

Model Number	81720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the wire tip was a little split.A 140x25cm fathom -16 was selected for use.During preparation, it was noted that the tip of the guidewire was a little split.The procedure was completed by opening another of the same guidewire.No patient complications were reported.
Event or Problem Description
It was reported that the wire tip was a little split.A 140x25cm fathom -16 was selected for use.During preparation, it was noted that the tip of the guidewire was a little split.The procedure was completed by opening another of the same guidewire.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).The device was returned for analysis and the evaluation was completed on 06sep2024.Visual inspection was performed, and no damages were detected on the device.Based on analysis of the returned product, the reported allegation could not be confirmed, as no damages were found during the product inspection that could have contributed to the reported issue.

• Brand Name: FATHOM -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19930385
• Report Number: 2124215-2024-45787
• Device Sequence Number: 16834362
• Product Code: DQX
• UDI-Device Identifier: 08714729764410
• UDI-Public: 08714729764410
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K170636
• 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): 10/01/2024

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: 06/21/2026
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0031871516
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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 Sex: Unknown