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

Model Number	45031
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); 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	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the moderately tortuous right superficial femoral artery.A solent omni catheter was selected for a thrombectomy procedure.During the procedure, the catheter was difficult to track.Consequently, the catheter became kinked after a few passes and appeared to have a break in the middle shaft of hypotube.The device was removed from the patient intact.The procedure was completed with a solent proxi catheter device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated bt mfr: the device was returned for analysis.Inspection of the device revealed multiple shaft kinks.No blood was inside the device or inside the waste bag.The catheter was successfully functionally tested with no alarms present; however, a shaft kink and fracture/leak was observed.A shaft kink and fracture leak were observed located at 38 cm from the tip.
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the moderately tortuous superficial femoral artery.A solent omni catheter was selected for a thrombectomy procedure.During the procedure, the catheter was difficult to track.Consequently, the catheter became kinked after a few passes and appeared to have a break in the middle shaft of hypotube.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; 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: 20315664
• Report Number: 2124215-2024-59214
• Device Sequence Number: 8099278
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/31/2024

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: 12/10/2025
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0033659324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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