MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 45032

Device Problem Leak/Splash (1354)

Patient Problems Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411); Respiratory Insufficiency (4462)

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that the angiojet catheter had a leak, and the patient experienced an embolism.During a thrombosis assessment of the arteriovenous fistula of a dialysis patient, it was decided to perform a thrombectomy of the right humeral artery using an angiojet solent proxi catheter after having observed the presence of a suspended thrombus in the process of re-permeabilization in this artery.The procedure had to be interrupted quickly after 20 seconds for syncope with a drop in blood pressure and 80% desaturation (recovered within a few minutes) suggestive of pulmonary embolism.At the same time, there was a significant leakage of blood observed upstream of the blood collection bag.The patient was transferred to the intensive care unit for treatment of the embolism.There were no further patient complications.

• Brand Name: ANGIOJET SOLENT PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 19162931
• MDR Text Key: 340807288
• Report Number: 2124215-2024-21278
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0031029082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention