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

Model Number	45031
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed target lesion was located in the severely tortuous and non-calcified femoral graft and superficial femoral artery.An angiojet solent omni catheter was used for thrombectomy procedure.While advancing to the target location, the device was required to make two 90 degree turns.During power pulse mode, thrombolytics were infused into the occluded lesion.However, the device developed a kink and fracture in the delivery shaft where the coiled silver section meets the purple plastic segment, near the tip.The device was removed intact, and the procedure was completed by replacing the catheter.No complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed target lesion was located in the severely tortuous and non-calcified femoral graft and superficial femoral artery.An angiojet solent omni catheter was used for thrombectomy procedure.While advancing to the target location, the device was required to make two 90 degree turns.During power pulse mode, thrombolytics were infused into the occluded lesion.However, the device developed a kink and fracture in the delivery shaft where the coiled silver section meets the purple plastic segment, near the tip.The device was removed intact, and the procedure was completed by replacing the catheter.No complications were reported.
Additional Manufacturer Narrative
The angiojet solent omni catheter was returned to the boston scientific for analysis.The catheter shaft displayed multiple bends and kinks.A functional testing was performed and the pump was inserted into the ultra drive unite console.The catheter primed, and the device functioned for a duration of 90 seconds in the thrombectomy mode.The device's pressure was within the regular range of 9.625 kpsi.A shaft kink/leak was observed during functional testing located 26.5cm from the tip.There were no errors nor priming issues observed during functional testing as the device ran as designed.

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18356395
• Report Number: 2124215-2023-71679
• Device Sequence Number: 17744325
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 10/20/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031475215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White