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

Model Number 45031

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that tip break and difficulty removal of the catheter occurred.Vascular access was obtained via the radial artery.The totally occluded, concentric target lesion was located in an arteriovenous fistula on the left forearm.The lesion contained a greater than 90 degree bend.An angiojet solent omni was used in a thrombectomy procedure.The catheter was opened, inserted and primed into the console and changed the setting to power pulse mode.It was then inserted through the sheath and injected 5cc of actilyse/syline mix, however, it was noted that the distal tip of the catheter was looking like it came apart from the catheter.The physician removed the device and resistance was felt.The device was completely removed by carefully withdrawing the wire and maneuvering of the sheath.It was confirmed that the tip of the catheter was broken off inside the patient and was hanging halfway inside the distal tip of the sheath after it was removed.The procedure was discontinued.There were no patient complications reported and patient's status was stable.

Manufacturer Narrative

A2 - age at time of event: 18 years or older 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 and microscopic examination revealed no damages.Device to device interaction test was performed by inserting a test guidewire into the tip.The wire was able to pass through the device with no resistance.Inspection of the device presented no damage or irregularities.

Event Description

It was reported that tip break and difficulty removal of the catheter occurred.Vascular access was obtained via the radial artery.The totally occluded, concentric target lesion was located in an arteriovenous fistula on the left forearm.The lesion contained a greater than 90 degree bend.An angiojet solent omni was used in a thrombectomy procedure.The catheter was opened, inserted and primed into the console and changed the setting to power pulse mode.It was then inserted through the sheath and injected 5cc of actilyse/syline mix, however, it was noted that the distal tip of the catheter was looking like it came apart from the catheter.The physician removed the device and resistance was felt.The device was completely removed by carefully withdrawing the wire and maneuvering of the sheath.It was confirmed that the tip of the catheter was broken off inside the patient and was hanging halfway inside the distal tip of the sheath after it was removed.The procedure was discontinued.There were no patient complications reported and patient's status was stable.

• 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: 13930290
• MDR Text Key: 288050643
• Report Number: 2134265-2022-03318
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027360206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• 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 Sex: Male