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

Model Number	H74908526021
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign material was noted.A 5f expo diagnostic guide catheter was selected for use in a diagnostic angiogram procedure.During preparation, the physician was not able to advance a starter guidewire through the catheter.When they decided to backload the wire, a plastic piece was lodged inside the catheter.They were able to push the plastic out.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that a foreign material was noted.A 5f expo diagnostic guide catheter was selected for use in a diagnostic angiogram procedure.During preparation, the physician was not able to advance a starter guidewire through the catheter.When they decided to backload the wire, a plastic piece was lodged inside the catheter.They were able to push the plastic out.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
The device was not returned for analysis.A photo was provided to boston scientific for review as part of our investigation.The photo depicts a section of the inner liner of the device delaminated and separated.H3 other text : media.
Additional Manufacturer Narrative
This report is being filed to correct the model number in response to an fda request.Because the lot number is unknown, we are unable to provide the unique identifier (udi) # or the device manufacture date.However, we have provided the device identifier (di) portion of the unique identifier (udi) #.The device was not returned for analysis.A photo was provided to boston scientific for review as part of our investigation.The photo depicts a section of the inner liner of the device delaminated and separated.
Event or Problem Description
It was reported that a foreign material was noted.A 5f expo diagnostic guide catheter was selected for use in a diagnostic angiogram procedure.During preparation, the physician was not able to advance a starter guidewire through the catheter.When they decided to backload the wire, a plastic piece was lodged inside the catheter.They were able to push the plastic out.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: EXPO
• Common Device Name: 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: 17914623
• Report Number: 2124215-2023-53866
• Device Sequence Number: 12425537
• Product Code: DQO
• UDI-Device Identifier: 08714729366461
• UDI-Public: 08714729366461
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74908526021
• Device Catalogue Number: 7845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 06/12/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/19/2023; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown