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

Model Number	7760
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.A model-5f expo multipack 145 (5pkx3) was selected for percutaneous coronary intervention (pci).During the procedure, the expo catheter multipack found to have a stricture in the 'l' catheter of multiple catheters in the pack which made them difficult to flush and impossible to pass a wire.Furthermore, it was noted that the device was fractured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
H6: device codes: corrected from difficult to insert a150206 to difficult to advance a150205.
Event or Problem Description
It was reported that the device was fractured.A model-5f expo multipack 145 (5pkx3) was selected for percutaneous coronary intervention (pci).During the procedure, the expo catheter multipack found to have a stricture in the 'l' catheter of multiple catheters in the pack which made them difficult to flush and impossible to pass a wire.Furthermore, it was noted that the device was fractured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

• Brand Name: EXPO GUIDE CATHETER
• 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; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18730450
• Report Number: 2124215-2024-08118
• Device Sequence Number: 8276009
• Product Code: DQO
• UDI-Device Identifier: 08714729187875
• UDI-Public: 08714729187875
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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 Expiration Date: 09/22/2025
• Device Model Number: 7760
• Device Catalogue Number: 7760
• Device Lot Number: 0060498231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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