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

Model Number 45031

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/21/2022

Event Type  malfunction  

Event Description

It was reported that a catheter break occurred.The target lesion was located in the left femoral artery.An angiojet solent omni was used in a thrombectomy procedure.During the procedure, the catheter had difficulty advancing in the 6f sheath.As a result, the catheter broke in half and there was difficulty to remove it from the sheath.An angiojet solent dista was selected, however, it was difficult to advance the device.The procedure was completed with a different device.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the solent omni thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Visual examination revealed multiple kinks to the shaft.The shaft is separated 56.2cm from the strain relief.The hypotube is separated 57.1cm from the strain relief.Microscopic examination revealed no additional damages.Inspection of the device presented no other damage or irregularities.Product analysis confirmed the shaft is separated and there are kinks which would contribute to the difficulty to advance and remove.

Event Description

It was reported that a catheter break occurred.The target lesion was located in the left femoral artery.An angiojet solent omni was used in a thrombectomy procedure.During the procedure, the catheter had difficulty advancing in the 6f sheath.As a result, the catheter broke in half and there was difficulty to remove it from the sheath.An angiojet solent dista was selected, however, it was difficult to advance the device.The procedure was completed with a different device.There were no patient complications.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13542131
• MDR Text Key: 285682048
• Report Number: 2134265-2022-01580
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027205145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male