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

Model Number 45031

Device Problem Defective Device (2588)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that the procedure was cancelled.An angiojet solvent omni catheter was advanced for treatment.During procedure, the system failed to read the catheter.Therefore, another of the same device was opened but still the same failure occurred.Due to this event, the procedure was cancelled.There were no patient complications reported.

Manufacturer Narrative

Initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of the solent omni thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Visual and microscopic examination revealed no damages.Functional testing was performed by placing the device in the angiojet ultra console.Functional testing consisted of running the complaint device through the full priming cycle and 90 seconds in thrombectomy.The device ran within normal range (10.14 kpsi), without any leaks or any errors/alarms from the console.Inspection of the device presented no damage or irregularities.Product analysis could not confirm the reported barcode issue.

Event Description

It was reported that the procedure was cancelled.An angiojet solent omni catheter was advanced for treatment.During procedure, the system failed to read the catheter.Therefore, another of the same device was opened but still the same failure occurred.Due to this event, the procedure was cancelled.There were no patient complications reported.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16099541
• MDR Text Key: 308268053
• Report Number: 2124215-2022-55573
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

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 Expiration Date: 06/20/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027797701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• 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