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

Model Number	7840
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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 03/01/2024 as no event date was reported.
Event or Problem Description
It was reported that a foreign material was present in the device.An expo diagnostic catheter was selected for use.During preparation, while passing the wire through the expo catheter, a white piece came out from catheter and attached to distal portion of the wire.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 03/01/2024 as no event date was reported.Device evaluated by mfr.: the device was returned for analysis.Returned device consisted of an expo diagnostic catheter with a starter guidewire inserted in the lumen and exiting the distal tip.A portion of the liner was detached and stuck to the guidewire.A photo attached to the complaint record depicts the expo catheter and the starter guidewire with a piece of the liner detached from the lumen of the expo and attached to the starter wire.Product analysis confirmed the reported events as the liner was detached and separated.A corrective action investigation has been initiated to identify the cause of delamination of the catheter polyurethane inner lining.In addition, boston scientific initiated a medical device removal (97171742-fa) of the expo diagnostic catheter on 21 march 2024.
Event or Problem Description
It was reported that a foreign material was present in the device.An expo diagnostic catheter was selected for use.During preparation, while passing the wire through the expo catheter, a white piece came out from catheter and attached to distal portion of the wire.The procedure was completed with another of the same device.No patient complications reported.

• 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: 19034431
• Report Number: 2124215-2024-19960
• Device Sequence Number: 12510574
• Product Code: DQO
• UDI-Device Identifier: 08714729187691
• UDI-Public: 08714729187691
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 09/26/2025
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060500724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97171742-FA
• Patient Sequence Number: 1
• Patient Sex: Unknown