MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number	45032
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the arm fistula.An angiojet solent proxi catheter was used in a thrombectomy procedure.During the procedure, it was noted that the shaft 3cm distal from the tip at the proximal radiopaque band was kinked and broke off in the patient.A snare was used to get the broken piece and was retrieved successfully.The procedure was completed with another of the same device.No patient complications were reported and patient was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the arm fistula.An angiojet solent proxi catheter was used in a thrombectomy procedure.During the procedure, it was noted that the device 3cm distal from the tip at the proximal radiopaque band was kinked and broke off in the patient.A snare was used to get the broken piece and was retrieved successfully.The procedure was completed with another of the same device.No patient complications were reported and patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the product return contained an angiojet solent proxi.The assembly, supply line, shaft, saline supply and tip were all visually examined for potential damage.The tip of the device was completely torn off and twisted, and two kinks were noticed on the catheter at 17.5 cm and 34 cm from the tip.As well as this, there appeared to be some clotting and blockage in the catheter, at the site of the tear.A functional test could not be performed due to the damage on the device.Inspection of the device confirms the allegation of the kinked catheter and detachment of device tip.

• Brand Name: ANGIOJET SOLENT PROXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12318197
• Report Number: 2134265-2021-10347
• Device Sequence Number: 19738154
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0027414189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR