MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number	86200
Medical Device Problem Codes	Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material present in the tip of the device.During preparation of the ultra ice plus catheter for insertion into the patient, it was not possible to flush the catheter.A foreign object was discovered in the distal tip.The catheter was replaced and the procedure was performed without issue.
Additional Manufacturer Narrative
Correction: note additional device code of improper flow or infusion.Analysis of returned product revealed that there were residues inside the imaging window which confirmed the reported "foreign object was found".No visible damage to the catheter was noted.The device was also functionally tested and it performed as intended (device was able to flush); consequently, not confirming the reported "it could not flush".Although the device was able to be flushed during testing, according to the event description the issue occurred during insertion; this, along with the residues found on the device, leads to the belief that the "clogging" most likely occurred due to procedural factors coming in contact with the device and, in turn, decreasing its functional and physical capabilities.The investigation conclusion is adverse event related to procedure.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that foreign material present in the tip of the device.During preparation of the ultra ice plus catheter for insertion into the patient, it was not possible to flush the catheter.A foreign object was discovered in the distal tip.The catheter was replaced and the procedure was performed without issue.

• Brand Name: ULTRA ICE PLUS
• Common Device Name: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8608202
• Report Number: 2134265-2019-05232
• Device Sequence Number: 2295022
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 01/08/2021
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0023160352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1