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

Model Number	7840
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a foreign fiber was observed on the device.A 5f expo guide catheter was selected for a diagnostic coronary angiogram.The device was prepared and flushed using normal processes.Upon further inspection outside the patient prior to use, it was noted that there was a fiber on the tip of the catheter.The device was not used.A new catheter was obtained and used without problem.No patient complications were reported.
Additional Manufacturer Narrative
Mfr site address 2: no.20905 int.A.Col.,cd.Industrial, 22444 device evaluated by mfr: an expo diagnostic catheter was returned for analysis.The catheter hub and shaft were visually and microscopically inspected for damage.Visual examination revealed no damages.Microscopic examination revealed foreign matter in the tip of the device.There is what appears to be dried saline on the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a foreign fiber was observed on the device.A 5f expo guide catheter was selected for a diagnostic coronary angiogram.The device was prepared and flushed using normal processes.Upon further inspection outside the patient prior to use, it was noted that there was a fiber on the tip of the catheter.The device was not used.A new catheter was obtained and used without problem.No patient complications were reported.

• Brand Name: EXPO GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8646802
• Report Number: 2134265-2019-05862
• Device Sequence Number: 19336998
• Product Code: DQO
• UDI-Device Identifier: 08714729187936
• UDI-Public: 08714729187936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 01/23/2021
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060168041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1