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

Model Number 45031

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Event Description

It was reported that a loss of aspiration occurred.An angiojet solent omni catheter and an angiojet spiroflex vg catheter were selected for a thrombectomy procedure.However, during the procedure, it was noted that the devices would not aspirate.The procedure was completed by doing a balloon angioplasty.There were no patient complications reported and the patient was fine.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9652787
• MDR Text Key: 178647381
• Report Number: 2134265-2020-00771
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020

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: 08/26/2021
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0024631029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• 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