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

Model Number 45031

Device Problems Suction Problem (2170); Material Perforation (2205)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device returned contained an angiojet solent omni.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The catheter had multiple kinks along the catheter shaft.A functional test was performed.The pump was placed into the ultra drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product, with a pressure of 10.646 kpsi.There is no confirmation for the complaints allegation of shaft perforation or loss of aspiration.

Event Description

It was reported that loss of aspiration occurred.An angiojet solent omni catheter was used for the thrombectomy procedure.During the procedure, it was reported there was a hole in the shaft of the catheter causing diminished suction power.The device continued to pump saline when aspiration was lost and the procedure was completed successfully.No patient complications were reported.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12744996
• MDR Text Key: 279845011
• Report Number: 2134265-2021-13194
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (y/n): N
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/03/2021

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: 05/15/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027758153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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