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

Model Number	45031
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29-sep-2023.It was reported that luer lock nut was damage.An angiojet solent omni was selected for use for thrombectomy procedure.During procedure, it was observed that the back wire clip on the catheter was malfunctioning.However, it was further reported that the physician experienced difficulty tracking over the wire, as it failed to exit the catheter when pressure was applied.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a broken hypotube.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of an angiojet solent omni catheter.The catheter shaft showed multiple bends and kinks.The device was received with the tru-seal lock missing.A spare guidewire lock was used during functional testing.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 36 cm from the tip, the hypotube was broken and completely separated.The x-ray was used to verify hypotube separation.The device could not be functionally tested due to the extreme damage on the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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: 17967256
• Report Number: 2124215-2023-57659
• Device Sequence Number: 7670444
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/19/2023

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: 04/30/2025
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0032257697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Sex: Unknown