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

Model Number	109681-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Septic Shock (2068); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The target lesion was located in the popliteal artery.The procedure went well, however, the doctor noted that the patient might develop compartment syndrome.No complications related to the device, or the procedure were noted; however, the patient subsequently deceased.
Additional Manufacturer Narrative
H6 - patient codes: updated.
Event or Problem Description
It was reported that the patient died.The target lesion was located in the popliteal artery.The procedure went well, however, the doctor noted that the patient might develop compartment syndrome.Post-procedure, the patient exhibited some unknown comorbidities.No complications related to the device, or the procedure were noted; however, the patient subsequently deceased.
Additional Manufacturer Narrative
B5 describe event or problem: updated.H6 - patient codes: updated.H6 - impact codes: updated.
Event or Problem Description
Locationit was reported that the patient died.The target lesion was located in the popliteal artery.The procedure went well, however, the doctor noted that the patient might develop compartment syndrome.Post-procedure, the patient exhibited some unknown comorbidities.No complications related to the device, or the procedure were noted; however, the patient subsequently deceased.It was further reported that the procedure took place in the mid to late afternoon.The angiojet was used in the popliteal artery which was completely occluded all the way down.There were no issues with the angiojet catheter.Due to the patient's leg being cold for a long period of time (due to the occlusion/lack of blood flow), it would have been ideal to gradually introduce blood flow back to the artery.However, it was noted that the angiojet was able to open the vessel very quickly which is why it was thought that the patient may experience compartment syndrome.During recovery, the patients leg began swelling.The patient was taken straight to the operating room, and a unilateral fasciotomy was performed.Post-procedure, the patient showed signs of shock, with abnormal lab results.The patient's condition deteriorated overnight, and they were declared brain dead the following morning.The patient passed away that day.The exact cause of death was not confirmed but was believed to be some form of shock, possibly septic shock.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22161532
• Report Number: 2124215-2025-35733
• Device Sequence Number: 7484765
• Product Code: DXE
• UDI-Device Identifier: 08714729889663
• UDI-Public: (01)08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 109681-001
• Device Catalogue Number: 109681-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/24/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Unknown