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

Model Number	8080
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unknown material came out of the device.An expo angiographic catheter was selected for use.During the procedure, a tubular material or unknown foreign body was noted and removed from catheter.No patient complications were reported.
Event or Problem Description
It was reported that unknown material came out of the device.An expo angiographic catheter was selected for use.During the procedure, a tubular material or unknown foreign body was noted and removed from catheter.No patient complications were reported.It was further reported the procedure was a graft study using omnipaque.A 0.35 non-boston scientific exchange wire was used to remove the expo catheter that they had used to image the graft.Once the catheter was removed from the wire the unknown material was seen protruding from the end of the catheter.
Additional Manufacturer Narrative
Upon receipt, the expo angiographic catheter was thoroughly inspected and analyzed.To preserve the reported unknown material, the device was not soaked during disinfection.Visual inspection noted that the inner liner of the catheter was separated/torn, approximately 7.5 cm from the tip.Analysis confirmed there was no evidence of inner liner material restriction (or inner liner blockage) within the internal lumen of the returned catheter.Fourier transform infrared (ftir) spectroscopy confirmed the unknown material was consistent with the inner liner.Material analysis also revealed matter consistent with the contrast used during the procedure (i.E., omnipaque).A photo was provided that depicts two tubular pieces of the inner liner.The clinically reported unknown material observed protruding from the device following the procedure was determined to be pieces of the separated inner catheter liner.
Event or Problem Description
It was reported that unknown material came out of the device.An expo angiographic catheter was selected for use.During the procedure, a tubular material or unknown foreign body was noted and removed from catheter.No patient complications were reported.It was further reported the procedure was a graft study using omnipaque.A 0.35 non-boston scientific exchange wire was used to remove the expo catheter that they had used to image the graft.Once the catheter was removed from the wire the unknown material was seen protruding from the end of the catheter.

• 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): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20315053
• Report Number: 2124215-2024-56473
• Device Sequence Number: 7862543
• Product Code: DQO
• UDI-Device Identifier: 08714729192985
• UDI-Public: 08714729192985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 02/21/2026
• Device Model Number: 8080
• Device Catalogue Number: 8080
• Device Lot Number: 0060540478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 12/09/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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