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

Model Number 45031

Device Problem Suction Problem (2170)

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

Event Date 04/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The shaft showed no damage.Functional testing was completed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed and ran as designed for 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.The device functioned as design with no abnormalities noticed.An aspiration test was performed by inserting the devices tip into a 100cc beaker.The device was activated, and the device removed fluid as designed.No leaks were noticed during functional analysis.Inspection of the remainder of the device damage, revealed no damage or irregularities.

Event Description

It was reported that loss of aspiration occurred.An angiojet solent omni catheter was used in a thrombectomy procedure.During the procedure, it was noted that the catheter would not perform thrombectomy and aspiration was lost while the device continue to pump saline.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
• 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: 11829328
• MDR Text Key: 250843766
• Report Number: 2134265-2021-05899
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2021

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: 12/29/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0026839292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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