MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET AVX; CATHETER, EMBOLECTOMY

Model Number	45026
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device separated inside the patient.An angiojet avx catheter was selected for a thrombectomy procedure.At the commencement of the procedure when the catheter was inside the patient's body, the tip partially separated from the catheter.The wire was also noted to be coming out of the side of the tip.The catheter and tip were then successfully removed completely from the patient without complication.A new device of the same model was used to complete the procedure without further complications.There was no harm to the patient and the patient was fine post procedure.

• Brand Name: ANGIOJET AVX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8421178
• Report Number: 2134265-2019-02441
• Device Sequence Number: 2051206
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133629
• 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
• Report Date (Section B): 03/14/2019

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: 07/01/2020
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 22568689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1