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

Model Number 45031

Device Problems Break (1069); Defective Device (2588)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that the catheter fractured.An angiojet solent omni catheter was selected for use in an angioplasty with thrombectomy procedure.The catheter was advanced to the treatment area, and powerpulse was initiated.After powerpulse, thrombectomy mode was activated and the when the catheter was moving distal to proximal, the catheter started to elongate.A new solent oni catheter was used, however, this catheter elongated as well when moving distal to proximal.Upon removing it, the catheter broke in half.The procedure did not continue.There were no patient complications.

Event Description

It was reported that the catheter fractured.An angiojet solent omni catheter was selected for use in an angioplasty with thrombectomy procedure.The catheter was advanced to the treatment area, and powerpulse was initiated.After powerpulse, thrombectomy mode was activated and the when the catheter was moving distal to proximal, the catheter started to elongate.A new solent oni catheter was used, however, this catheter elongated as well when moving distal to proximal.Upon removing it, the catheter broke in half.The procedure did not continue.There were no patient complications.It was further reported that the procedure was completed with this device since the physician already managed to clear the clots with one pass from proximal to distal before noticing the exterior catheter was unraveled and was pulled out.The shaft break right in the middle and was outside of the patient's body.

• 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: 13052820
• MDR Text Key: 282565710
• Report Number: 2134265-2021-16054
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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: 07/05/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027896046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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