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

Model Number 45031

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the patient experienced an embolism.An angiojet ultra system console and an angiojet solent omni thrombectomy catheter were selected for thrombectomy treatment.During catheter advancement it was observed that blood was traveling into the tubing while the catheter was being introduced in to the patient.The device was not activated.When the device was in power pulse mode the blood flow back was more active.The physician reset the device by turning it off and on and re-priming.The fluid flowback was still present.The angiojet solent omni catheter was discarded, and another angiojet solent omni was selected.The same problem was encountered with the second catheter.The physician elected to proceed with surgery to remove the clot from the patient.During surgery it was observed that the patient clot dislodged.The dislodged clot was removed manually using fogarty balloons.There was no further patient complications and the patient was fine post procedure.

• 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: 9432548
• MDR Text Key: 169683807
• Report Number: 2134265-2019-15197
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111182
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0024423467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• 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
• Treatment: ANGIOJET ULTRA SYSTEM CONSOLE
• Patient Outcome(s): Other