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

Model Number 45030

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

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

Event Date 05/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned to for analysis.The product return contained an angiojet solent dista.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed a hypotube fracture 25.5 cm from the tip.A functional test was performed.The pump was placed into the ultra drive console and the device displayed an under pressure error message.The device was unable to run, due to the pressure being below specifications.No further damage or discrepancies were noted on the rest of the catheter upon visual inspection.

Event Description

Reportable based on the device analysis completed on 02-sep-2021.It was reported that error message occurred.An angiojet solent dista was used for thrombectomy.The catheter failed to prime throughout the procedure, and the device requested that the angiojet system be replaced with another catheter in order to continue working normally.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed hypotube fracture.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12540893
• MDR Text Key: 273594323
• Report Number: 2134265-2021-12061
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

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: 08/31/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0026199149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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