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

Model Number	M00499100
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that a catheter break / detachment occurred.An ultra ice plus ultrasound imaging catheter and another manufacturer¿s snare were selected for use during an implantable cardioverter defibrillator (icd) lead extraction procedure in the right atrium.During a twisting maneuver with the snare retrieval device, the catheter was entrapped while it was rotating and therefore became damaged.During retrieval of the devices, the piezoelectric crystal broke and detached from the catheter body.It was noted the detachment ¿probably¿ occurred inside the sheath.All components were removed from the patient without problems and the procedure was completed using a different device.There were no patient complications.

• 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: 7341241
• Report Number: 2134265-2018-01975
• Device Sequence Number: 1393223
• Product Code: DXK
• UDI-Device Identifier: 08714729904373
• UDI-Public: 08714729904373
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160173
• 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
• Report Date (Section B): 02/22/2018

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: 05/05/2019
• Device Model Number: M00499100
• Device Catalogue Number: 9910
• Device Lot Number: 20607150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1