MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	7760
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was present in the device.An expo guide catheter was selected for use.During the procedure, when the catheter was being flushed prior to insertion into the patient, a piece of plastic came out on the wire before entering into the patient.The procedure was completed with a different device.No patient complications reported.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to (b)(6) 2024 as no event date was reported.
Event or Problem Description
It was reported via medwatch mw5150064 that foreign material was present in the device.An expo guide catheter was selected for use.During the procedure, when the catheter was being flushed prior to insertion into the patient, a piece of plastic came out on the wire before entering into the patient.The procedure was completed with a different device.No patient complications reported.It was further reported that the catheter was not allowing the wire to pass through.
Additional Manufacturer Narrative
B3 - date of event updated from 01/01/2024 to (b)(6) 2024.Media provided from the facility was reviewed.Although media depicted a photo of white foreign matter and there is visibility of a device tip and unknown location on the shaft, the media was deemed as inconclusive as no device was returned to bsc to confirm the difficulty to track over wire and origin of the white foreign matter.

• Brand Name: EXPO GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18592240
• Report Number: 2124215-2024-01652
• Device Sequence Number: 8116883
• Product Code: DQO
• UDI-Device Identifier: 08714729187875
• UDI-Public: 08714729187875
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 09/27/2025
• Device Model Number: 7760
• Device Catalogue Number: 7760
• Device Lot Number: 0060500299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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