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

Model Number	7840
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the diagnostic expo fr4 distal separated from main shaft in the sheath.A model-5f expo fr4 (5pk) expo guide catheter was advanced for treatment; however, the catheter separated while in the sheath.Multiple snares were attempted to remove the fragment.The catheter fragment remained in the patient's arm.The patient was taken to surgery and a bypass graft in the arm was placed.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13017969
• Report Number: 2134265-2021-15886
• Device Sequence Number: 14749538
• Product Code: DQO
• UDI-Device Identifier: 08714729187691
• UDI-Public: 08714729187691
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: 07/30/2023
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060310965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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