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

Model Number	45026
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the pump assembly, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Blood was present inside the device and almost 100 ml of blood in the attached waste bag, when received.The introducer sheath was received on the distal shaft of the catheter and was able to be removed with no issues.There was no guidewire stuck in the angiojet device or returned for analysis.Visual examination of the device revealed that there were numerous kinks throughout the shaft of the device.The distal shaft of the catheter was stretched and buckled from the proximal to distal markerbands.Microscopic examination revealed that the hypotube was separated from the jet body.Functional testing with a test guidewire was not possible due to the damage of the distal shaft.Inspection of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the catheter became stuck on the guidewire.An angiojet avx catheter was selected for a fistulagram in the brachial artery.After a long pass, the catheter became stuck on the unspecified guidewire.The catheter and the guidewire were pulled out together.The artery was re-wired and another of the same catheter was used to successfully complete the procedure.There were no patient complications reported.

• 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: 8712237
• Report Number: 2134265-2019-07094
• Device Sequence Number: 2446327
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/19/2019

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: 03/18/2021
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0023819556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1