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

Model Number 45031

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487); Material Deformation (2976)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that catheter break occurred.An angiojet solent omni was used for thrombectomy procedure.During the procedure, the device stopped priming at 10s.The device still could not continue to prime after reset.During inspection, it was noted that there was a rupture in the catheter and the shaft was kinked.The device had not entered the patient when it ruptured, and the procedure was completed with another of the same device.No complications were reported, and the patent was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Media was returned in the form of videos.The videos were reviewed which showed a supply line separation.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed no damage.The supply/effluent line showed a severe kink and broken supply line.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 29 cm from the hub/manifold, the supply line was broken and completely separated.The device could not be functionally tested due to the extreme damage on the device.No pressure reading was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that catheter break occurred.An angiojet solent omni was used for thrombectomy procedure.During the procedure, the device stopped priming at 10s.The device still could not continue to prime after reset.During inspection, it was noted that there was a rupture in the catheter and the shaft was kinked.The device had not entered the patient when it ruptured, and the procedure was completed with another of the same device.No complications were reported, and the patent was stable post procedure.

• 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: 18643396
• MDR Text Key: 334804978
• Report Number: 2124215-2024-02782
• 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: 03/05/2024

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: 0031328470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG