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

Model Number 964

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vasoconstriction (2126); Unspecified Tissue Injury (4559)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported that a spasm occurred, the tip detached requiring additional intervention.A 5f expo diagnostic guide catheter was selected for use during a left heart catheterization.During the procedure, the patient experienced a spasm and the device was unable to be removed from the right radial artery.The physician began to torque the catheter causing it to break inside the artery.Once the catheter was removed, it was noted that the tip was missing.The detached catheter tip was removed along with portions of tissue from the right radial artery using a snare.No further patient complications were reported.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPO; c. industrial lt.001 mz.105; tijuana, baja california ; MX
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18271472
• MDR Text Key: 329774636
• Report Number: 2124215-2023-63909
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 964
• Device Catalogue Number: 964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention