MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number	M00499120
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event : over 18 years.(b)(4).
Event or Problem Description
It was reported that the a foreign substance was noted.An ultra ice plus imaging catheter was selected for use.During preparation, it was noted that the sterile water injected to the tip of the catheter looked cloudy.Furthermore, the device was inserted to the patient's body but physician discontinued the usage and removed the device from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for evaluation.No issues were noted upon visual inspection.The catheter was flushed normally upon functional inspection and no issues were noted.The impedance testing showed a good unit wave form.Good square image appeared in the ilab system upon image characterization testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that the a foreign substance was noted.An ultra ice plus imaging catheter was selected for use.During preparation, it was noted that the sterile water injected to the tip of the catheter looked cloudy.Furthermore, the device was inserted to the patient's body but physician discontinued the usage and removed the device from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.

• Brand Name: ULTRA ICE PLUS¿
• Common Device Name: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7362456
• Report Number: 2134265-2018-02275
• Device Sequence Number: 11164784
• Product Code: DXK
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 07/13/2019
• Device Model Number: M00499120
• Device Catalogue Number: 9912
• Device Lot Number: 20881358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1