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

Model Number	7840
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
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 that the catheter broke off in the patient and they required surgical intervention to remove it.An expo diagnostic catheter was selected for use.During the procedure, the catheter broke off in the patient and they required surgical intervention to remove it.No further patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 03/01/2024 as no event date was reported.F10 patient codes changed from foreign body in patient e2008 to no clinical signs, symptoms or conditions e2403.F10 device codes changed from fracture a040101 to detachment of device or device component a0501.
Event or Problem Description
It was reported that the catheter broke off in the patient and they required surgical intervention to remove it.An expo diagnostic catheter was selected for use.During the procedure, the catheter broke off in the patient and they required surgical intervention to remove it.No further patient complications were reported.It was further reported that the distal half to two thirds of the separated catheter were what was stuck inside the patient's arm just above the brachial area up through the subclavian artery area.The device became so twisted but it appears to have detached upon attempts to remove it from the body.After which it broke off and had to be surgically removed.

• 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: 19015890
• Report Number: 2124215-2024-19322
• Device Sequence Number: 15494481
• Product Code: DQO
• UDI-Device Identifier: 08714729187691
• UDI-Public: 08714729187691
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2025
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060519445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown