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

Model Number	7840
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch (b)(4) that catheter break and vascular dissection occurred.The patient presented for left heart catheterization.The expo guide catheter was entered right antecubital.When the exam was completed and the catheter was being withdrawn there was a loss of waveform and a possible kink was noticed.Several withdrawal attempts were made and it was then noticed the catheter was out of the artery.The catheter had broken off and punctured the artery.The patient was immediately taken to the operating room for removal of the device fragment from the right brachial artery.A cutdown was performed and the saphenous vein bypass reversed.The catheter was retrieved and the patient discharged the next morning.
Event or Problem Description
It was reported via medwatch mw5105624 that catheter break and vascular dissection occurred.The patient presented for left heart catheterization.The expo guide catheter was entered right antecubital.When the exam was completed and the catheter was being withdrawn there was a loss of waveform and a possible kink was noticed.Several withdrawal attempts were made and it was then noticed the catheter was out of the artery.The catheter had broken off and punctured the artery.The patient was immediately taken to the operating room for removal of the device fragment from the right brachial artery.A cutdown was performed and the saphenous vein bypass reversed.The catheter was retrieved and the patient discharged the next morning.

• 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: 13297118
• Report Number: 2134265-2022-00451
• Device Sequence Number: 11609513
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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: 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/19/2022
• 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