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

Model Number 45030

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Age of time of event: 18yrs or older.Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were microscopic and visually inspected.Blood was present inside the device and 100ml of blood in the attached waste bag, when received.Inspection of the device revealed that there was a severe kink 2.5cm proximal of the tip.Functional testing was performed by placing the device in the angiojet ultra console.The complaint device failed to prime and the 'check saline supply' error was displayed on the console.The shaft at the kink was microscopically examined and it was revealed that the hypotube had a crack and kinked, indicating that the device was kinked prior to the crack.The shaft was kinked causing the hypotube to become kinked and then crack.When the hypotube is cracked, the device will not be working and won't prime and the console will continue to try and prime the catheter, causing 'check saline supply' error to display on the console and the device not to primed/work.

Event Description

Reportable based on device analysis completed on 16-december-2020.It was reported that an error message was displayed.The target lesion was located in the iliac vein.An angiojet solent dista catheter was used for a thrombectomy procedure.During priming, it was noted that check saline supply error occurred.The system was reset and priming worked fine.However, during procedure, a check for catheter kinks error was displayed.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, device analysis revealed a hypotube break.

• Brand Name: ANGIOJET SOLENT DISTA
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11037746
• MDR Text Key: 222344741
• Report Number: 2134265-2020-18111
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

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: 08/28/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0026154976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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