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

Model Number 45031

Device Problems Leak/Splash (1354); Suction Problem (2170)

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

Event Date 07/09/2023

Event Type  malfunction  

Event Description

It was reported that there was loss of aspiration.An angiojet solent omni was selected for thrombectomy procedure.During procedure, it was noted that the mid shaft was leaking, and the suction was less strong.The procedure was completed with a new device, same model.There were no patient complications.

Event Description

It was reported that there was loss of aspiration.An angiojet solent omni was selected for thrombectomy procedure.During procedure, it was noted that the mid shaft was leaking, and the suction was less strong.The procedure was completed with a new device, same model.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.The pump was inserted into the ultra drive unit console.The catheter primed, and the device functioned for a period of 90 seconds in the thrombectomy mode.The catheter tip was placed into a 100 ml beaker and ran for approximately 30 seconds at which point it was verified the device was aspirating normally.The devices pressure was within the normal range.A leak was observed during functional testing at the kink located at 76.5 cm from the tip.During functional testing no errors or priming issues were observed, the device ran as designed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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: 17414463
• MDR Text Key: 320088272
• Report Number: 2124215-2023-40109
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031467011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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 Race: Asian