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

Model Number 45031

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that catheter fracture occurred.The patient was sedated under local anesthesia for a venous thrombosis of lower limb at the popliteal vein.An angiojet solent omni catheter was advanced for treatment.During the procedure, the catheter got stuck in the sheath after entering the patient's body.It was then noted that the device was fractured at the tip as it was severely deformed.The catheter was difficult to remove, however, the devices were removed, and the procedure was cancelled due to this event.There were no complications reported.

Manufacturer Narrative

E1: initial reporter facility name: the (b)(6) hospital.

Event Description

It was reported that catheter fracture occurred.The patient was sedated under local anesthesia for a venous thrombosis of lower limb at the popliteal vein.An angiojet solent omni catheter was advanced for treatment.During the procedure, the catheter got stuck in the sheath after entering the patient's body.It was then noted that the device was fractured at the tip as it was severely deformed.The catheter was difficult to remove, however, the devices were removed, and the procedure was cancelled due to this event.There were no complications reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device evaluated by mfr.: angiojet solent omni catheter returned for analysis.Inspection of the device revealed multiple shaft kinks.There were no signs of blood anywhere on the device.Functional testing failed due to an under-pressure alarm message.The complaint was confirmed for under-pressure issues related to a hypotube separation.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19050987
• MDR Text Key: 339815928
• Report Number: 2124215-2024-19887
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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
• Device Operator: Health Professional
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031536379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 46 KG