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 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that tip detached and withdrawal difficulty occurred.The target lesion was located in the iliac vein of the lower limb.An angiojet solent omni catheter was used in a thrombectomy procedure.During the procedure under thrombectomy mode, the device alerted that the catheter needed to be re-primed.The catheter could not be withdrawn normally after trying to remove.After the catheter was simply pulled out, it was noted that the tip was detached in the sheath.The procedure was completed with another of the same device.There were no patient complications reported and patient's status was stable.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: the device returned to boston scientific for analysis.The product return contained an angiojet solent omni.The assembly, supply line, shaft, saline supply and tip were all visually examined for potential damage.The catheter shaft showed a heavily stretched shaft with a detached tip.The stretching was 2.5cm long, at the initial location of the distal marker band.The proximal saddle was displaced 0.5cm from its intended location, with the marker band damaged and further displaced another 1.5cm, for a total of 2cm off the intended location.Along with this damaged marker band, a fractured hypotube was noted at the same location.A functional test was performed.The pump was placed into the ultra drive console but the device gave an under pressure error.The devices pressure was not within normal range.Due to this, a functional test cannot be performed.Testing of the device confirms the detached tip and error messages.However the difficulty in removal cannot be confirmed.

Event Description

It was reported that tip detached and withdrawal difficulty occurred.The target lesion was located in the iliac vein of the lower limb.An angiojet solent omni catheter was used in a thrombectomy procedure.During the procedure under thrombectomy mode, the device alerted that the catheter needed to be re-primed.The catheter could not be withdrawn normally after trying to remove.After the catheter was simply pulled out, it was noted that the tip was detached in the sheath.The procedure was completed with another of the same device.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: 13443940
• MDR Text Key: 285165906
• Report Number: 2134265-2022-01087
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0028017101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 68 KG