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

Model Number	7840
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via user medwatch mw5111200 that removal difficulties occurred.The patient presented with st elevation myocardial infarction (stemi).The target lesion was located in the right femoral artery.The 5f expo wr (5pk) catheter was inserted into the sheath.The physician was having difficulty engaging the artery and had to twist the device to get the catheter engaged.When they panned out to look at the arteries the catheter was kinked right outside the sheath and inside the artery.Upon withdrawal, the catheter would not come out.The patient was sent to surgery to remove the device.

• Brand Name: EXPO GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15401968
• Report Number: 2124215-2022-34894
• Device Sequence Number: 6216730
• Product Code: DQO
• UDI-Device Identifier: 08714729249412
• UDI-Public: 08714729249412
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: 03/17/2023
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060288016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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