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

Model Number	45031
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	02/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter break occurred.An angiojet solent omni catheter was used for treatment.During the procedure while in thrombectomy mode, the catheter was kinked and appeared that the metal coils inside the shaft had come apart.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed 2 severe kinks located 39cm and 40.5cm from the tip.Functional testing was competed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed, and the device was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was not within the normal range.With the pressure being out of specification and the severe kinking noticed, the shaft was dissected and showed a broken hypotube at the 40.5cm location due to the severe kinking that took place.With a broken hypotube an under-pressure condition would occur.Leaks were noticed at the kinked areas.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that catheter break occurred.An angiojet solent omni catheter was used for treatment.During the procedure while in thrombectomy mode, the catheter was kinked and appeared that the metal coils inside the shaft had come apart.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11505400
• Report Number: 2134265-2021-03441
• Device Sequence Number: 2777068
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111182
• 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): 04/12/2021

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: 11/02/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0026554130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1